Mitral valve treatment techniques

- Valtech Cardio Ltd.

A method is provided for treating mitral valve regurgitation, including inserting a band around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of chordae tendineae of one or more types of chordae tendineae selected from the group consisting of: second-order chordae tendineae and third-order chordae tendineae. The method also includes applying pressure to the posterior cusp by inflating the band.

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Description
CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a divisional application of U.S. Ser. No. 11/908,906 to Gross et al., entitled, “Mitral valve treatment techniques,” filed on Dec. 8, 2008, now U.S. Pat. No. 8,608,797, which is the U.S. national phase application of PCT/IL2006/000342, which claims the benefit of:

(a) U.S. Provisional Patent Application 60/662,616 to Gross et al., filed Mar. 17, 2005, and

(b) U.S. Provisional Patent Application 60/700,542 to Gross et al., filed Jul. 18, 2005. All Both of these applications are assigned to the assignee of the present application and are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to surgical methods and apparatus, and specifically to methods and apparatus for mitral valve treatment.

BACKGROUND OF THE INVENTION

Mitral valve regurgitation is a disorder in which the mitral valve does not close properly. During systole, a healthy mitral valve prevents oxygenated blood from flowing back (regurgitating) from the left ventricle to the left atrium. Regurgitation caused by a defective mitral valve reduces cardiac output, increasing the risk of progressive heart failure. Treatments for mitral valve regurgitation include valve replacement and strengthening the valve annulus by implanting a mechanical support ring or other structure (generally called valve annuloplasty).

The chordae tendineae are commonly classified according to their insertion sites on the mitral cusps. The first-order (also called primary or marginal) chordae insert on the cusp free edges, the second-order (also called “strut”) chordae insert on the ventricular surface of the cusps, usually near the junction between the rough and smooth zones, and the third-order (also called tertiary or basal) chordae originate directly from the trabeculae cameae of the left ventricular wall, and attach to the cusps near the annulus of the mitral valve.

US Patent Application Publication 2005/0010287 to Macoviak et al., which is incorporated herein by reference, describes techniques for supplementing, repairing, or replacing a native heart valve. The techniques employ an implant that is adapted to extend adjacent a valve annulus. The implant includes a mobile neoleaflet element that occupies the space of at least a portion of one native valve leaflet. The implant mimics the one-way valve function of a native leaflet, to resist or prevent retrograde flow. The implant restores normal coaptation of the leaflets to resist retrograde flow, thereby resisting eversion and/or prolaspe, which, in turn, reduces regurgitation.

US Patent Application Publication 2004/0193191 to Starksen et al., which is incorporated herein by reference, describes methods for treating a cardiac valve annulus, comprising contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. The publication also describes devices including an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

US Patent Application Publication 2004/0148020 to Vidlund et al., which is incorporated herein by reference, describes techniques for improving the function of a valve (e.g., a mitral valve) by positioning an implantable device outside and adjacent the heart wall such that the device alters the shape of the heart wall acting on the valve. The implantable device may alter the shape of the heart wall acting on the valve by applying an inward force and/or by circumferential shortening (cinching). The shape change of the heart wall acting on the valve is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example, to reduce regurgitation.

US Patent Application Publication 2004/0148019 to Vidlund et al., which is incorporated herein by reference, describes techniques for improving the function of a valve (e.g., a mitral valve) by positioning a spacing filling device outside and adjacent the heart wall such that the device applies an inward force against the heart wall acting on the valve. A substantially equal and opposite force may be provided by securing the device to the heart wall, and/or a substantially equal and opposite outward force may be applied against anatomical structure outside the heart wall. The inward force is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example. The space filling device may be implanted by a surgical approach, a transthoracic approach, or a transluminal approach, for example. The space filling portion may be delivered utilizing a delivery catheter navigated via the selected approach, and the space filling portion may be expandable between a smaller delivery configuration and a larger deployed configuration.

US Patent Application Publication 2004/0138745 to Macoviak et al., which is incorporated herein by reference, describes medical devices for improving heart valve function, including leaflet retainers, a neo-annulus, neo-leaflet, and a framework.

US Patent Application Publication 2004/012983 to Mortier et al., which is incorporated herein by reference, describes a device for heart valve repair including at least one tension member having a first end and second end. A basal anchor is disposed at the first end of the tension member and a secondary anchor at the second end. The publication describes a method including the steps of anchoring the basal anchor proximate a heart valve and anchoring the secondary anchor at a location spaced from the valve such that the chamber geometry is altered to reduce heart wall tension and/or stress on the valve leaflets.

U.S. Pat. No. 6,629,534 and US Patent Application Publication 2004/0039442 to St. Goar et al., which are incorporated herein by reference, describe techniques for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, is repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures are modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber.

US Patent Application Publication 2003/019974 to Lee et al., which is incorporated herein by reference, describes an annuloplasty system for repairing a heart valve, comprising a surgical implant including a member having first and second end portions. The implant member further is configured and/or adapted to form a partial ring along a portion of one of the valve annulae of a patient's heart such as the mitral or tricuspid valve annulus. The implant member is axially elastic such that it can axially expand and contract and includes first and second anchors extending from the end portions of the implant member. The anchors are adapted to anchor the implant in tissue such as the mitral or tricuspid valve annulus. The system is described as facilitating tissue plication (e.g., of the posterior annulus of the mitral valve or the annulus of the tricuspid valve) and reinforcement of a valve annulus.

US Patent Application Publication 2003/0191528 to Quijano et al., which is incorporated herein by reference, describes an expandable annular ring for implantation in a valvular annulus and its percutaneous use. The ring comprises a plurality of stenting elements made of a first shape-memory material having a first shape-transition temperature, wherein the first shape-memory material expands to a preshape when the first shape-memory material is heated to above the first shape-transition temperature; and a plurality of anchoring elements made of a second shape-memory material having a second shape-transition temperature that is higher than the first shape-transition temperature, wherein the second shape-memory material expands to the second preshape when the second shape-memory material is heated to above the second shape-transition temperature.

US Patent Application Publications 2004/0260393 to Rahdert et al. and 2004/0127982 to Machold et al., which are incorporated herein by reference, describe techniques using an implant that is sized and configured to attach in, on, or near the annulus of a dysfunctional heart valve. In use, the implant extends either across the minor axis of the annulus, or across the major axis of the annulus, or both. The implant is described as restoring to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation.

US Patent Application Publication 2004/0260394 to Douk et al., which is incorporated herein by reference, describes a cardiac valve annulus compressor comprising a generally cylindrical main body having plain and barbed ends and an actuator portion. Barbs disposed on the barbed end are engageable with the valve annulus. The length of the circumference of the barbed end is responsive to movement of the actuator portion. The annulus compressor can be delivered percutaneously or surgically.

US Patent Application Publication 2004/0236419 to Milo, which is incorporated herein by reference, describes methods for reconfiguring an atrioventricular heart valve that use systems comprising a partial or complete annuloplasty rings proportioned to reconfigure a heart valve that has become in some way incompetent, a pair of trigonal sutures or implantable anchors, and a plurality of staples which may have pairs of legs that are sized and shaped for association with the ring at spaced locations along its length. These systems are described as permitting relative axial movement between the staples and the ring, whereby a patient's heart valve can be reconfigured in a manner that does not deter subtle shifting of the native valve components. Shape-memory alloy material staples may have legs with free ends that interlock following implantation. Annuloplasty rings may be complete or partial and may be fenestrated. One alternative method routes a flexible wire, preferably of shape-memory material, through the bights of pre-implanted staples. Other alternative systems use linkers of shape-memory material having hooked ends to interengage with staples or other implanted supports which, following implantation, decrease in effective length and pull the staples or other supports toward one another so as to create desired curvature of the reconfigured valve. These linkers may be separate from the supports or may be integral with them and may have a variety of shapes and forms. Various of these systems may be implanted non-invasively using a delivery catheter.

US Patent Application Publication 2004/0243227 to Starksen et al., which is incorporated herein by reference, describes techniques for facilitating positioning of a cardiac valve annulus treatment device. The publication describes methods including advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Odell J A et al., in an article entitled “Early Results of a Simplified Method of Mitral Valve Annuloplasty,” Circulation 92:150-154 (1995), which is incorporated herein by reference, studied the outcome of three different annuloplasty techniques: commissural annuloplasty, complete ring annuloplasty, and an unmeasured, posterior, partial ring annuloplasty. They concluded that postoperative valve function obtained by unmeasured posterior annuloplasty, as assessed by degree of regurgitation, transvalvular gradient, and valve area, was similar to that obtained by measured, complete ring annuloplasty and superior to that found in patients having commissural annuloplasty.

US Patent Application Publication 2003/0078465 to Pai et al., which is incorporated herein by reference, describes techniques for testing degenerative, congestive heart disease and related valvular dysfunction. Percutaneous and minimally invasive surgical tensioning structures are implantable within various major coronary blood-carrying conduit structures (arteries, veins and branching vessels), into or through myocardium, or into engagement with other anatomic structures that impact cardiac output to provide tensile support to the heart muscle wall which resists diastolic filling pressure while simultaneously providing a compressive force to the muscle wall to limit, compensate or provide therapeutic treatment for congestive heart failure and/or to reverse the remodeling that produces an enlarged heart. In some embodiments, the tensioning structures are used to apply tension to papillary muscles and/or chordae tendineae to reposition the valve leaflets to reduce/eliminate regurgitation, to limit the motion of the leaflets to improve/restore the function of cardiac valves; and to directly reposition the valve leaflets to prevent prolapse or other abnormalities of the leaflets and to prevent associated deficiencies.

US Patent Application Publication 2003/0018358 to Saadat, which is incorporated herein by reference, describes techniques for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. Mechanical clips are implanted over the leaflets of a valve, e.g., in the heart, either alone or after thermal treatment to cause the valve to close more tightly. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve. channel. Alternatively, individual anchors with a tensioning element, like a suture, are described as being useful for approximating the valves towards each other.

U.S. Pat. No. 6,626,899 to Houser et al., which is incorporated herein by reference, describes techniques for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. The apparatus comprises a catheter in communication with an end effector which induces a temperature rise in an annulus of tissue surrounding the leaflets of a valve or in the chordae tendineae sufficient to cause shrinkage, thereby causing the valves to close more tightly. Mechanical clips can also be implanted over the valve either alone or after the thermal treatment. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve channel.

US Patent Application Publication 2005/0222678 to Lashinski et al., which is incorporated herein by reference, describes methods and devices for applying pressure to an adjacent tissue structure, such as the annulus of the mitral valve. An adjustable implant is described with an elongate control line having a distal end connected to the implant and a proximal end spaced apart from the implant. The device enables post implantation adjustment, by accessing the proximal end of the control line and manipulating the control line to adjust the implant.

US Patent Application Publication 2005/0096740 to Langberg et al., which is incorporated herein by reference, describes a mitral annuloplasty and left ventricle restriction device adapted to be transvenously advanced and deployed within the coronary sinus and, in some embodiments, other coronary veins. The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

SUMMARY OF THE INVENTION

In some embodiments of the present invention, a mitral valve treatment device comprises a band, a distal coupling element, and a proximal coupling element. The device is adapted to be placed around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of third-order chordae tendineae. The proximal and distal coupling elements are adapted to be coupled to a first chorda tendinea and a second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the plurality of third-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve. Such coupling typically tightens the annulus and thereby treats mitral valve regurgitation. Alternatively or additionally, the space is defined by a plurality of second-order chordae tendineae, and/or the distal and/or proximal end of the band is adapted to be coupled to a second-order chorda tendinea.

In some embodiments of the present invention, a mitral valve treatment device comprises an inflatable band. The band is adapted to be placed around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of third-order chordae tendineae. After placement, the band is inflated and sealed, causing the band to press against the posterior cusp, the chordae tendineae, and the ventricular wall, thereby applying pressure to and supporting the posterior cusp. For some applications, inflation of the band additionally holds the band in place. For some applications, the band comprises neither a distal nor a proximal coupling element, or comprises only a single coupling element.

In some embodiments of the present invention, a method for treating mitral valve regurgitation comprises inserting a band around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of third-order chordae tendineae. The method further comprises coupling a distal end and a proximal end of the band to a first chorda tendinea and a second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the plurality of third-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve. Such coupling typically tightens the annulus and thereby treats mitral valve regurgitation. Alternatively or additionally, the space is defined by a plurality of second-order chordae tendineae, and/or the distal and/or proximal end of the band is coupled to a second-order chorda tendinea.

In some embodiments of the present invention, apparatus for treating a mitral valve comprises an outward force applicator adapted to be placed around between 90 and 270 degrees of a mitral valve of a heart. The force applicator is configured such that at least two regions thereof (typically end regions) apply force to a wall of a heart chamber in a vicinity of the commissural cusps of the mitral valve. Such outwardly-applied force draws the commissural cusps away from one another, stretching the mitral valve and thereby bringing the posterior and anterior cusps of the valve closer to one another. The device is thus useful for treating mitral valve regurgitation.

In some embodiments of the present invention, the force applicator is adapted to be placed in a space defined by (a) a ventricular wall, (b) a ventricular surface of at least one of the mitral valve cusps in a vicinity of an annulus of the mitral valve, and (c) a plurality of third-order chordae tendineae. Alternatively or additionally, the space is defined by a plurality of second-order chordae tendineae. Further alternatively, the force applicator is adapted to be placed in a left atrium of the heart, in contact with or in a vicinity of the mitral valve.

In some embodiments of the present invention, the force applicator comprises one or more coupling elements, which are adapted to hold the force applicator in place after placement. For some applications, the coupling elements comprise one or more protrusions, oriented on the force applicator such that the protrusions contact and grip the wall of the heart. Typically, the protrusions are positioned in a vicinity of the ends of the force applicator, and/or along the length of the force applicator, such as in a vicinity of a middle of the force applicator. For other applications, the coupling elements are adapted to be coupled to the mitral valve, and/or to one or more chordae tendineae, such as third-order chordae tendineae, or second-order chordae tendineae. For these applications, the coupling elements may comprise, for example, hooks, sutures, or staples.

There is therefore provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including:

a band having a distal and proximal ends, the band adapted to be placed:

    • around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve,
    • in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of third-order chordae tendineae; and

distal and proximal coupling elements, coupled to the band at the distal and proximal ends thereof, respectively, and adapted to be coupled to a first chorda tendinea and a second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the plurality of third-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve.

In an embodiment, each of the first and second chordae tendineae includes one of the plurality of third-order chordae tendineae, and the distal and proximal coupling elements are adapted to be coupled to the respective ones of the plurality of third-order chordae tendineae.

In an embodiment, the distal and proximal coupling elements are adapted to be coupled to the first and second chordae tendineae such that the band tightens the annulus of the valve. Alternatively or additionally, the distal and proximal coupling elements are adapted to be coupled to the first and second chordae tendineae such that the band applies pressure to the posterior cusp. For some applications, the distal and proximal coupling elements are adapted to be coupled to the first and second cusp of the valve. For some applications, the distal and proximal coupling elements are adapted to be coupled to the first and second chordae tendineae such that the band does not squeeze an anterior cusp of the valve and the posterior cusp together.

For some applications, the distal and proximal coupling elements include respective hooks, adapted to be hooked to the first and second chordae tendineae, respectively.

For some applications, the band is generally elliptical in cross-section. Alternatively, the band is flat.

For some applications, the band includes at least one sensor selected from the group consisting of: a wireless position sensor, and a navigation sensor. For some applications, the band includes a steering mechanism.

For some applications, the band includes a shape memory alloy, and the shape memory alloy causes the band to assume a curved shape during placement of the band.

For some applications, the band includes a tension element, adapted to shorten a length of the band. For some applications, at least a portion of the band includes an elastic material, adapted to shorten a length of the band.

For some applications, the band is coated with a substance selected from the group consisting of: a drug, and a radiopaque coating.

For some applications, the band is adapted to be placed around no portion of an anterior cusp of the valve. For some applications, the band is adapted to be placed such that a length of a first portion of the band that surrounds the at least a portion of the posterior cusp is at least 5 times a total length of that portion of the band that surrounds at least a portion of an anterior cusp of the valve.

For some applications, the band includes a distal stop, and the distal coupling element is adapted to slide along the band until blocked by the distal stop.

For some applications, the band includes a plurality of bands, the bands adapted to be placed in series around between 90 and 270 degrees of the mitral valve.

For some applications, the apparatus includes an elongated insertion element, adapted to releasable engage the proximal end of the band.

In an embodiment, the proximal coupling element is adapted to slide along the band and subsequently be locked to the band. For some applications, a portion of the band in a vicinity of the proximal end is shaped so as to define a first set of teeth, an interior surface of the proximal coupling element is shaped to as to define a second set of teeth, and the teeth are configured to allow distal advancement of the proximal coupling element along the band, and to not allow proximal retraction of the proximal coupling element along the band.

For some applications, the apparatus includes a crimping mechanism, adapted to be placed around the proximal coupling element and to crimp the proximal coupling element to the band.

For some applications, a portion of the band in a vicinity of the proximal end is shaped so as to define a first set of teeth, an interior surface of the proximal coupling element is shaped so as to define a second set of teeth, and the crimping element is adapted to crimp the proximal coupling element to the band by crimping at least a portion of the second set of teeth to at least a portion of the first set of teeth. For some applications, the crimping mechanism includes an inflation element, adapted, upon inflation thereof, to crimp the proximal coupling element to the band.

For some applications, the band is shaped so as to define one or more indentations therein, and the proximal coupling element includes a tension clip, adapted to engage at least one of the indentations, so as to lock the proximal coupling element to the band.

For some applications, the band is adapted to be placed around between 120 and 240 degrees of the mitral valve, such as between 150 and 210 degrees of the mitral valve.

There is also provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including:

a band having distal and proximal ends, the band adapted to be placed:

    • around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve,
    • in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of second-order chordae tendineae; and

distal and proximal coupling elements, coupled to the band at the distal and proximal ends thereof, respectively, and adapted to be coupled to a first chorda tendinea and a second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the plurality of second-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve.

There is further provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including a band adapted to be placed:

    • around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve,
    • in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of third-order chordae tendineae,

the band configured such that inflation thereof applies pressure to the posterior cusp.

In an embodiment, the band is configured such that inflation thereof holds the band in place.

For some applications, the apparatus includes a liquid for inflating the band, the liquid adapted to at least partially solidify after inflation of the band therewith.

In an embodiment, the band is not configured to be coupled to any portion of the heart, other than by the inflation thereof.

There is still further provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including a band adapted to be placed:

    • around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve,
    • in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the mitral valve, and (c) a plurality of second-order chordae tendineae,

the band configured such that inflation thereof applies pressure to the posterior cusp.

In an embodiment, the band is configured such that inflation thereof holds the band in place.

There is yet further provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including:

a stent, adapted to be placed while in a contracted state around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of third-order chordae tendineae; and

an inflation element, positioned within the stent, and adapted to expand the stent upon inflation, such that the stent applies pressure to the posterior cusp.

In an embodiment, the stent includes at least one coupling element, adapted to be coupled to a chorda tendinea.

For some applications, the stent includes a plurality of stents, adapted to be placed in series around between 90 and 270 degrees of the mitral valve.

There is additionally provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including:

inserting a band around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b)a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of third-order chordae tendineae; and

coupling a distal end and a proximal end of the band to a first chorda tendinea and a second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the plurality of third-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve.

For some applications, inserting includes inserting the band via an ascending aorta.

For some applications, the band includes at least one sensor selected from the group consisting of: a wireless position sensor, and a navigation sensor, and inserting includes inserting the band at least in part responsively to a signal generated by the sensor.

For some applications, the band includes a distal stop and a distal coupling element, and coupling the distal end of the band to the first chorda tendinea includes:

advancing the band until the distal stop reaches a vicinity of a first chorda tendinea;

advancing the distal coupling element over the band until the distal coupling element reaches the distal stop; and

coupling the distal coupling element to the first chorda tendinea.

In an embodiment, the band includes a proximal coupling element, and coupling includes:

coupling the distal end of the band to the first chorda tendinea;

thereafter, sliding the proximal coupling element along the band until the band has a desired length between the distal end and the proximal coupling element; and

locking the proximal coupling element to the band.

For some applications, coupling includes, after locking the proximal coupling element, clipping a portion of the band proximal to the proximal coupling element. For some applications, coupling includes, after locking the proximal coupling element, releasing the band from an elongated insertion element, and withdrawing the insertion element from the heart.

For some applications, a portion of the band in a vicinity of the proximal end includes a first set of teeth, an interior surface of the proximal coupling element includes a second set of teeth, the teeth are configured to allow distal advancement of the proximal coupling element along the band, and to not allow proximal retraction of the proximal coupling element along the band, and locking the proximal coupling element includes advancing the proximal coupling element until the band has the desired length.

There is yet additionally provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including:

inserting a band around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of second-order chordae tendineae; and

coupling a distal end and a proximal end of the band to a first chorda tendinea and a second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the plurality of second-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve.

There is still additionally provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including:

inserting a band around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of third-order chordae tendineae; and

applying pressure to the posterior cusp by inflating the band.

There is also provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including:

inserting a band around between 90 and 270 degrees of a mitral valve, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of second-order chordae tendineae; and

applying pressure to the posterior cusp by inflating the band.

There is further provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including:

inserting a stent in a contracted state around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of third-order chordae tendineae; and

applying pressure to the posterior cusp by expanding the stent by inflating an inflation element positioned within the stent.

There is still further provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including a force applicator adapted to be placed around at least a portion of a mitral valve of a heart, and configured such that at least two regions of the force applicator apply, to a wall of a chamber of the heart in a vicinity of commissural cusps of the mitral valve, force sufficient to bring a posterior cusp and an anterior cusp of the mitral valve closer to one another than a distance therebetween in the absence of the force applicator.

In an embodiment, the applicator is adapted to be placed in a space defined by (a) a ventricular wall, (b) a ventricular surface of the positioning cusp in a vicinity of an annulus of the valve, and (c) a plurality of third-order chordae tendineae. Alternatively, in an embodiment, the applicator is adapted to be placed in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of second-order chordae tendineae.

In an embodiment, the applicator is adapted to be placed in a left atrium of the heart, in contact with or in a variety of the mitral valve.

For some applications, the applicator is generally elliptical in cross-section. Alternatively, the applicator is flat.

For some applications, the applicator is coated with a substance selected from the group consisting of: a drug, and a radiopaque coating.

For some applications, the applicator is adapted to be placed around no portion of the anterior cusp. For some applications, the applicator is adapted to be placed such that a length of a first portion of the applicator that surrounds at least a portion of the posterior cusp is at least 5 times a total length of that portion of the applicator that surrounds at least a portion of the anterior cusp.

For some applications, the applicator is configured to enhance fibrosis between at least a portion of the applicator and the wall of the chamber.

For some applications, the applicator includes at least one sensor selected from the group consisting of: a wireless position sensor, and a navigation sensor. For some application, the applicator includes a steering mechanism.

For some applications, the applicator has distal and proximal ends, and the applicator includes an adjustment mechanism, which is configured to change a distance between the distal end and the proximal end of the applicator.

For some applications, the applicator is shaped so as to define one or more protrusions, oriented such that the protrusions contact the wall of the chamber of the heart upon placement of the applicator.

In an embodiment, the applicator includes one or more coupling elements, adapted to hold the applicator in place around the at least a portion of the valve. Alternatively, the coupling elements are adapted to be coupled to respective chordae tendineae.

In an embodiment, the applicator is adapted to be placed around between 90 and 270 degrees of the mitral valve, such as around between 120 and 240 degrees of the initial valve, e.g., around between 150 and 210 degrees of the mitral valve.

In an embodiment, the applicator is configured such that after placement of the applicator, and before the at least two regions apply the force, there is a gap between the applicator and the wall of the chamber. For some applications, the applicator is configured such that the force applied by the at least two regions reduces a distance between the applicator and the wall of the chamber in a vicinity of the gap. For some applications, the applicator is configured such that the force applied by the at least two regions immediately reduces the distance. Alternatively, the applicator is configured such that the force applied by the at least two regions reduces the distance within one month of application of the force.

In an embodiment, the at least two regions include two end regions of the force applicator, and the force applicator is configured such that at least the two end regions apply the force. For some applications, the applicator includes at least one screw in a vicinity of at least one of the end regions, the screw configured such that rotation thereof adjust a degree of pushing of the at least one end region into the wall of the chamber.

There is additionally provided, in accordance with an embodiment of the present invention, apparatus for treating mitral valve regurgitation, including a force applicator adapted to be place around at least a portion of a mitral valve of a heart, and configured to:

apply force to a wall of a chamber of the heart, so as to change a shape of the heart around the mitral valve, and

enhance fibrosis between at least a portion of the force applicator and the heart wall, so as to help maintain the changed shape of the heart.

For some applications, a surface of the at least a portion of the applicator is roughened to enhance fibrosis. Alternatively or additionally, the at least a portion of the applicator is coated with a fibrosis-enhancing substance.

There is yet additionally provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including placing, around at least a portion of a mitral valve of a heart, a force applicator configured such that at least two regions of the force applicator apply, to a wall of a chamber of the heart in a vicinity of commissural cusps of the mitral valve, force sufficient to bring a posterior cusp and an anterior cusp of the mitral valve closer to one another than a distance therebetween in the absence of the force applicator.

For some applications, the applicator includes at least one sensor selected from the group consisting of: a wireless position sensor, and a navigation sensor, and placing include placing the applicator at least in part responsively to a signal generated by the sensor.

There is also provided, in accordance with an embodiment of the present invention, a method for treating mitral valve regurgitation, including placing, around at least a portion of a mitral valve of a heart, a force applicator configured to apply force to a wall of a chamber of the heart, so as to change a shape of the heart around the mitral valve, and to enhance fibrosis between at least a portion of the force applicator and the heart well, so as to help maintain the changed shape of the heart.

The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a mitral valve treatment device, in accordance with an embodiment of the present invention;

FIG. 2 is a schematic illustration of the device of FIG. 1 placed in a heart, in accordance with an embodiment of the present invention;

FIG. 3 is a schematic illustration of a pardon of the device of FIG. 1 placed around a portion of a posterior cusp of a mitral valve, in accordance with an embodiment of the present invention; and

FIG. 4 is a schematic illustration of a procedure for introducing the device of FIG. 1 into the heart, in accordance with an embodiment of the present invention;

FIG. 5 is a schematic illustration of a distal end of a catheter for introducing the device of FIG. 1 into the heart, in accordance with an embodiment of the present invention;

FIGS. 6A-B are schematic illustrations of a mitral valve before and after placement of the device of FIG. 1, respectively, in accordance with an embodiment of the present invention;

FIGS. 7A-B are schematic illustrations of the device of FIG. 1 during systole and diastole, respectively, in accordance with an embodiment of the present invention;

FIGS. 8A-B are schematic illustration of an over-the-wire implementation of the device of FIG. 1, in accordance with an embodiment of the present invention;

FIGS. 9A-B are schematic illustrations of a sliding and looking mechanism of the device of FIG. 1, in accordance with an embodiment of the present invention;

FIGS. 10A-C are schematic illustrations of another sliding and locking mechanism of the device of FIG. 1, in accordance with an embodiment of the present invention;

FIGS. 11A-B are schematic illustrations of yet another sliding and locking mechanism of the device of FIG. 1, in accordance with an embodiment of the present invention;

FIGS. 12A-B are schematic illustrations of a band clipping mechanism, in accordance with an embodiment of the present invention;

FIGS. 13A-B are schematic illustrations of a band release mechanism, in accordance with an embodiment of the present invention;

FIGS. 14A-B are schematic illustrations of an influence mechanism, in accordance with an embodiment of the present invention;

FIGS. 15A-B are schematic illustrations of another inflation technique, in accordance with an embodiment of the present invention;

FIG. 16 is a schematic illustration of a configuration of the device of FIG. 1, in accordance with an embodiment of the present invention;

FIGS. 17A-B are schematic illustrations of a stent adapted for treatment of a mitral valve, in accordance with an embodiment of the present invention.

FIG. 18 is a schematic illustration of a mitral valve treatment force applicator placed in a heart, in accordance with an embodiment of the present invention;

FIGS. 19A and 19B are schematic illustrations of a mitral valve before and after placement of the force applicator of FIG. 18, respectively, in accordance with an embodiment of the present invention;

FIG. 20 is a schematic illustration of a portion of the force applicator of FIG. 18 placed around a portion of a posterior cusp of the mitral valve, in accordance with an embodiment of the present invention;

FIGS. 21A and 21B are schematic illustrations of the mitral valve before and after expansion of the force applicator of FIG. 18, respectively, in accordance with an embodiment of the present invention;

FIGS. 22 and 23 are schematic illustrations of respective configurations of the force applicator of FIG. 18, in accordance with respective embodiments of the present invention;

FIG. 24 is a schematic illustration of a procedure for introducing the force applicator of FIG. 18 into the heart of a subject, in accordance with an embodiment of the present invention;

FIG. 25 is a schematic illustration of a distal end of a catheter for introducing the force applicator of FIG. 18 into the heart, in accordance with an embodiment of the present invention; and

FIGS. 26 and 27 are schematic illustrations of respective adjustment mechanisms for the force applicator of FIG. 18, in accordance with respective embodiments of the present invention.

 DETAILED DESCRIPTION OF EMBODIMENTS

FIG. 1 is a schematic illustration of a mitral valve treatment device 20, in accordance with an embodiment of the present invention. Device 20 typically comprise a flexible band 30, a distal coupling element 32 (e.g., a hook), and a proximal coupling element 34 (e.g., a hook). For some applications, band 30 is generally elliptical in cross-section (e.g., circular), while for other applications the band is flat, e.g., ribbon-shaped. Band 30 typically comprises a biocompatible material, such as a polymer or metal. For some applications, band 30 is coated with a drug and/or a radiopaque coating.

Reference is made to FIG. 2, which is a schematic illustration of band 30 placed in a heart 50, which is viewed from above the heart with the atria removed, in accordance with an embodiment of the present invention. Band 30 is adapted to be placed around between 90 and 270 degrees of a mitral valve 58 of a heart 50, including around at least a portion of a posterior cusp 56 of mitral valve 58, in a vicinity of an annulus 60 of mitral valve 58. For some applications, band 30 is adapted to be placed around between 120 and 240 degrees, such as between 150 and 210 degrees, e.g., about 180 degrees, of the mitral valve. For some applications, band 30 is adapted to be placed substantially only around all or a portion of posterior cusp 56, i.e., substantially not around any portion of an anterior cusp 59 of mitral valve 58. For example, the length of band 30 surrounding posterior cusp 56 is typically at least about 5 or at least about 10 times the length of any portion of band 30 that may be surrounding anterior cusp 59.

For some applications, band 30 is anchored in place by distal coupling element 32 and proximal coupling element 34, such that the band applies pressure to posterior cusp 56, thereby tightening annulus 60, supporting the posterior cusp, and bringing the posterior cusp closer to the anterior cusp. For applications in which a portion of band 30 is placed around a portion of anterior cusp 59, band 30 typically applies force substantially only to posterior cusp 56. Furthermore, band 30 is typically configured to apply pressure to posterior cusp 56, rather than to squeeze the posterior and anterior cusps together.

Reference is made to FIG. 3, which is a schematic illustration of a portion of band 30 placed around a portion of posterior cusp 56, in accordance with an embodiment of the present invention. Typically, band 30 is placed in the space defined by a ventricular wall 70 of left ventricle 72, a ventricular surface of posterior cusp 56 in a vicinity of annulus 60, and third-order chordae tendineae 74 (also called tertiary or basal chordae). (Third-order chordae 74, of which only two of many are shown in the figure for clarity of illustration, originate directly from the trabeculae carneae of ventricular wall 70, and attach to posterior cusp 56 in a vicinity of annulus 60.) Alternatively or additionally, the space is defined by second-order chordae tendineae (not shown in the figure). Typically, distal and proximal coupling elements 32 and 34 are coupled to first and second chordae tendineae, respectively, each of which is selected from the group consisting of: one of third-order chordae 74, a first-order chorda tendinea that inserts on a commissural cusp 78 of mitral valve 58 (shown in FIG. 2), and a second-order chorda tendinea (not shown in the figures). Typically, when in place, band 30 is in contact with one or more third- or second-order chordae tendineae, and/or the ventricular surface of posterior cusp 56 in the vicinity of annulus 60.

Alternatively or additionally, band 30 is placed around first-order chordae tendineae 80 that inserts on posterior cusp 56, anterior cusp 59, and/or commissural cusps 78 (configuration not shown in the figures). Further alternatively or additionally, band 30 is woven between the first-, second-, and/or third-order chordae.

Reference is made to FIG. 4, which is a schematic illustration of a procedure for introducing device 20 into heart 50 of a subject, in accordance with an embodiment of the present invention. Typically, device 20 is introduced into ventricle 72 by a catheter 81, which is typically introduced into ventricle 72 via an ascending aorta 82. A surgeon typically guides device 20 to a desired location using images of heart 50 captured using techniques known in the art. For some applications, device 20 comprises, e.g., at a distal and thereof, one or more wireless position sensors, such as those manufactured by Biosense, Inc. (New Brunswick, N.J.), or otherwise known in the art. Alternatively or additionally, device 20 comprises, e.g., at a distal end thereof, one or more sensors for aiding navigation, such as an ultrasound sensor, an infrared sensor, or an optical sensor. For some applications, device 20 comprises a steering mechanism, such as those known in the art of coronary catheter navigation. For some applications, band 30 comprises a shape memory alloy, such as nitinol, which causes the band to assume a curved shape, thereby assisting in navigating the band around the chordae tendineae. For some applications, the surgeon magnetically navigates band 30, such as using techniques described in U.S. Pat. Nos. 6,817,364 or 6,522,909 to Garibaldi et al., or U.S. Pat. No. 6,475,223 to Werp et al., which are incorporated herein by reference, mutatis mutandis.

Reference is made to FIG. 5, which is a schematic illustration of a distal end 84 of catheter 81, in accordance with an embodiment of the present invention. In this embodiment, the distal end of catheter 81 opens laterally, rather than at its end, so as to guide device 20 towards mitral valve 58 after the catheter is inserted into left ventricle 72.

Reference is made to FIGS. 6A-B, which are schematic illustrations of mitral valve 58 before and after placement of band 30, respectively, in accordance with an embodiment of the present invention. FIG. 6A shows mitral valve regurgitation occurring prior to the placement of band 30. FIG. 6A also shows band 30 as it is being placed around posterior cusp 56. FIG. 6B shows band 30 after it has been anchored in place around posterior cusp 56, thereby preventing regurgitation.

Reference is again made to FIG. 1. In an embodiment of the present invention, band 30 is adapted to tense, so as to shorten its length. For some applications, band 30 comprises a tension element 88, such as a spring. Alternatively or additionally, all or a portion of band 30 comprises an elastic material. For some applications, the tension serves to increase the force applied by band 30 to posterior cusp 56 after the band has been coupled to the chordae tendineae.

Reference is now made to FIGS. 7A-B, which are schematic illustrations of band 30 during systole and diastole, respectively, in accordance with an embodiment of the present invention. In this embodiment, band 30 comprises tension element 88, and/or band 30 comprises an elastic material. As shown in FIG. 7A, during systole tension element 88 contracts, increasing the pressure applied by band 30 to posterior cusp 56. During diastole, as shown in FIG. 7B, tension element 88 expands, reducing the pressure applied by band 30 to posterior cusp 56, and allowing mitral valve 58 to open.

Reference is now made to FIGS. 8A-B, which are schematic illustrations of an over-the-wire implementation of device 20, in accordance with an embodiment of the present invention. In this embodiment, band 30 comprises a distal stop 100, which, for example, may be spherical. Distal coupling element 32 is adapted to slide distally along band 30 until blocked by distal stop 100. During placement, band 30 is advanced until distal stop 100 reaches a vicinity of the chorda tendinea to which the distal end of the band will be coupled. Distal coupling element 32 is then advanced over band 30 until it reaches the distal end of the band. For example, the surgeon may advance catheter 81 over band 30 in order to push distal coupling element 32 to the distal end of the band. The surgeon then couples the coupling element to the chorda tendinea. Typically, the coupling of distal coupling element 32 to the chorda tendinea prevents subsequent proximal sliding of the coupling element. Alternatively, a locking mechanism is provided to hold coupling element 32 in place once it reaches distal stop 100. The use of distal stop 100 and the techniques described in this paragraph typically enable easier advancement of band 30 than in embodiments in which distal coupling element 32 is fixed to the distal end of band 30 during advancement.

Reference is again made to FIG. 1. In an embodiment of the present invention, proximal coupling element 34 comprises a sliding and locking mechanism 90. Sliding and locking mechanism 90 is configured to have a locked position and an unlocked position. When in the unlocked position, the mechanism is able to slide along band 30, and when in the locked position, the mechanism is fixed to the band. Typically, during placement of device 20 a surgeon couples distal coupling element 32 to a chorda tendinea at a desired location, and slides proximal coupling element 34 along band 30 so that band 30 has a desired length between the two coupling elements. The surgeon then locks mechanism 90, and clips the portion of band 30 proximal to proximal coupling element 34. For some applications, the surgeon locks and/or clips the excess portion before coupling proximal coupling element to a chorda tendinea, while for other applications the surgeon locks and/or clips the excess portion after coupling proximal coupling element to a chorda tendinea. Alternatively, rather than being clipped, band 30 is released from a release mechanism, as described hereinbelow with reference to FIGS. 13A-B.

Typically, the tension of band 30 is determined by the selected length of band 30 and the locations at which coupling elements 32 and 34 are coupled to the chordae. For some applications, the surgeon adjusts the tension of band 30 based on (a) tactile feedback, (b) a force measurement, and/or (c) another measurement, such as an electrocardiographic measurement, and/or a blood flow measurement made in the heart or elsewhere in the body. For some applications, band 30 comprises at least one tension or pressure sensor 86, which is adapted to measure the tension of band 30. Alternatively or additionally, device 20 comprises a tension control system 87 proximal to proximal coupling element 34.

Reference is made to FIGS. 9A-B, which are schematic illustrations of another sliding and locking mechanism 120 of band 30, in accordance with an embodiment of the present invention. Mechanism 120 comprises two interlocking sets of teeth. A first set of teeth 130 is coupled to or integrated into a proximal portion of band 30, and a second set of teeth 132 is coupled to or integrated into an interior surface of proximal coupling element 34. The teeth are configured to allow distal advancement of coupling element 34 over band 30, but to not allow proximal retraction of the coupling element. The surgeon distally advances coupling element 34 over band 30 so that band 30 has a desired length between the two coupling elements.

Reference is made to FIGS. 10A-C, which are schematic illustrations of yet another sliding and locking mechanism 140 of band 30, in accordance with an embodiment of the present invention. Mechanism 140 comprises two interlocking sets of teeth. A first set of teeth 150 is coupled to or integrated into a proximal portion of band 30, and a second set of teeth 152 is coupled to or integrated into an interior surface of proximal coupling element 34. When the coupling element is in an unlocked position, the first and second sets of teeth are not engaged with one another, such that the coupling element is able to advance distally over band 30, as shown in FIG. 10A. Catheter 81 comprises a crimping mechanism 153 in a vicinity of a distal end of the catheter. Crimping mechanism 153 typically comprises an expansion element 154, such as a balloon, which is coupled to an external source 156 of fluid (liquid or gas) pressure, via a pressure tube 158. Crimping mechanism 153 is adapted to be placed around the portion of proximal coupling element 34 having second set of teeth 152, as shown in FIG. 10A. Crimping mechanism 153 is configured such that expansion of expansion element 154 pushes second set of teeth 152 into contact with first set of teeth 150, crimping the first and second sets of teeth together, as shown in FIG. 10B. Such crimping locks coupling element 34 in place on band 30. After crimping, catheter 81 and crimping mechanism 153 are retracted, leaving coupling element 34 in place, as shown in FIG. 10C.

Reference is made to FIGS. 11A-B, which are schematic illustrations of still another sliding and locking mechanism 170, in accordance with an embodiment of the present invention. Mechanism 170 comprises a tension clip 172 that releasably engages one or more indentations 174 in band 30. Tension clip 172 is configured such that in its resting position, coupling portions 176 of the clip engage respective indentations 174, preventing movement of the clip, as shown in FIG. 11A. Applying force to release sites 178 of clip 172 changes the shape of the clip, causing coupling portions 176 to disengage from indentations 174, as shown in FIG. 11B. For some applications, release sites 178 also serve as coupling elements for coupling band 30 to the chordae tendineae, while for other applications, clip 172 comprises separate coupling elements (latter configuration not shown). In an embodiment, catheter 81 comprises one or more force application elements 180, which are configured to apply force to release sites 178, in order to disengage clip 172 from band 30. For some applications, force application elements 180 are inflatable, and are configured such that inflation thereof applies force to release sites 178.

Reference is made to FIGS. 12A-B, which are schematic illustrations of a band clipping mechanism 200, in accordance with an embodiment of the present invention. Clipping mechanism 200 is used to clip the portion of band 30 proximal to proximal coupling element 34, typically after the proximal coupling element has been locked in place. Clipping mechanism 200 comprises clippers 210, which are adapted to be introduced through catheter 81 over the proximal portion of band 30. Clippers 210 clip the band, and the clippers and the proximal portion of the band are withdrawn through catheter 81, leaving the distal portion of band 30 in place in the heart, as shown in FIG. 12B.

Reference is made to FIGS. 13A-B, which are schematic illustrations of a band release mechanism 220, in accordance with an embodiment of the present invention. The release mechanism is used to release band 30 from an insertion element 224, which is subsequently withdrawn through catheter 81. Therefore, in this embodiment, there is generally no need to clip the band. Release mechanism comprises a grasping element 226, which is adapted to releasably engage the proximal end of band 30. For some applications, the proximal end of band 30 comprises or is shaped to as to define a protrusion 228, such as a spherical protrusion, which grasping element 226 engages. Alternatively, release mechanism 220 comprises another coupling element such as a screw, which releasably engages the proximal end of band 30.

In an embodiment of the present invention, proximal coupling element 34 does not comprise sliding and locking mechanism 90 or any other length-adjusting mechanism, such that the length of band 30 is fixed. In this embodiment, the surgeon may or may not invasively or non-invasively measure or estimate the circumference of annulus 60 prior to choosing which length of band 30 to implant. For some applications of this embodiment, band 30 comprises band release mechanism 220, described hereinabove with reference to FIGS. 13A-B.

In an embodiment of the present invention, band 30 is configured such that distal and proximal coupling elements 32 and 34 push the chordae tendineae to which they are coupled, rather than pull the chordae. In this embodiment, band 30 is typically stiffer than in some other embodiments described herein.

In an embodiment of the present invention, band 30 comprises one or more supporting members configured to support posterior cusp 56. For some applications, the supporting members protrude from the band.

Reference is made to FIGS. 14A-B, which are schematic illustrations of an inflation mechanism 300, in accordance with an embodiment of the present invention. Inflation mechanism 300 comprises an inflatable sheath 310, placed around band 30, and an external source 312 of liquid (fluid or gas) pressure, which is coupled to an interior of sheath 310 via a pressure tube 314. During insertion of band 30, sheath 310 is typically uninflated. After insertion, pressure source 312 inflates sheath 310 by supplying a liquid or gas, such as saline solution, a liquid silicone, a liquid polymer, or a liquid polyurethane. After inflation, sheath 310 is sealed. Such inflation typically increases the support band 30 provides to posterior cusp 56. For some applications, sheath 310 is inflated with a liquid that completely or partially solidifies after inflation, such as into a flexible material.

FIGS. 15A-B are schematic illustrations of another inflation technique, in accordance with an embodiment of the present invention. In this embodiment, band 30 is itself inflatable, and sheath 310 need not be provided. The interior of band 30 is in fluid communication with external pressure source 312 via pressure tube 314. This embodiment may employ techniques described hereinabove with references to FIGS. 14A-B, mutatis mutandis.

FIG. 16 is a schematic illustration of a configuration of band 30, in accordance with an embodiment of the present invention. In this embodiment, band 30 is inflatable, such as by using one of the inflation techniques described hereinabove with reference to FIGS. 14A-B or 15A-B. For some applications, inflation band 30 comprises neither distal coupling element 32 nor proximal coupling element 34, nor any other anchoring means at either the distal or proximal ends of the band. (Alternatively, for some applications, band 30 comprises anchoring means at only a single one of its ends.) After the band is placed around all or a portion of posterior cusp 56, the band is inflated and sealed, causing the band to press against posterior cusp 56, chordae tendineae 74 (or, alternatively, the second-order chordae tendineae), and ventricular wall 70, thereby applying pressure to and supporting the posterior cusp, and typically holding band 30 in place.

Reference is made to FIGS. 17A-B, which are schematic illustrations of a stent 350 adapted for treatment of mitral valve 58, in accordance with an embodiment of the present invention. Stent 350 is adapted to be placed around between 90 and 270 degrees of mitral valve 58, including around at least a portion of posterior cusp 56. For some applications, stent 350 is adapted to be placed around between 120 and 240 degrees, such as between 150 and 210 degrees, e.g., about 180 degrees, of the mitral valve. For some applications, stent 350 is adapted to be placed substantially only around all or a portion of posterior cusp 56, i.e., substantially not around any portion of anterior cusp 59. For example, the length of stent 350 surrounding posterior cusp 56 is typically at least about 5 or at least about 10 times the length of any portion of stent 350 that may be surrounding anterior cusps 59.

Typically, stent 350, while in a contracted position, as shown in FIG. 17A, is placed in the space defined by ventricular wall 70 of left ventricle 72, a ventricular surface of posterior cusp 56 in a vicinity of annulus 60, and chordae tendineae selected from third-order chordae tendineae 74 and second-order chordae tendineae. Once in its desired position, stent 350 is expanded by inflating an inflation element 360 positioned within the stent. Inflation element 360 is removed, leaving stent 350 in place. Expansion of stent 350 applies pressure to and supports posterior cusp 56, and typically holds the stent in place.

For some applications, one or both ends of stent 350 are anchored in place by distal and/or proximal coupling elements (not shown in FIGS. 17A-B, but similar to distal and proximal coupling elements 32 and 34, as described hereinabove). Typically, the distal and proximal coupling elements are coupled to first and second chordae tendineae, respectively, each of which is selected from the group consisting of: one of third-order chordae 74, a first-order chorda tendinea that inserts on a commissural cusp 78 of mitral valve 58 (shown in FIG. 2), and a second-order chorda tendinea (not shown in the figures).

For some applications, a plurality of stents 350 are placed around mitral valve 58. The plurality of stents are typically arranged in series, and are optionally coupled to one another.

In an embodiment of the present invention, a method is provided for removing band 30 after it has been coupled to the chordae tendineae. The method comprises inserting a catheter or other elongated element into the heart, typically via ascending aorta 82, and navigating the catheter around the chordae tendineae in a direction opposite to the direction in which band 30 was navigated around the chordae during insertion of the band. When the catheter reaches the distal end of band 30, the catheter is coupled to the distal end. The catheter is then withdrawn, such that band 30 is pulled in the same direction as during the band's initial insertion. For example, if band 30 is initially inserted in a counterclockwise direction around the mitral valve as viewed from the left atrium, the catheter is inserted in a clockwise direction, and the catheter is withdrawn, pulling band 30, in a counterclockwise direction. Typically, before removing band 30, proximal coupling element 34 is removed from the band. For some applications, distal stop 100 is magnetic, and the catheter is magnetically coupled to the distal stop.

It will be appreciated that whereas band 30 has been generally described herein as comprising a single band, the scope of the present invention is not limited to a single band, and includes the use of multiple bands in series and/or in parallel with one another.

FIG. 18 is a schematic illustration of a mitral valve treatment outward force applicator 430 placed in heart 50, which is viewed from above the heart with the atria removed, in accordance with an embodiment of the present invention. Force applicator 430 is typically flexible, and, for some applications, is generally elliptical in cross-section (e.g., circular), while for other applications is flat, e.g., ribbon-shaped. Force applicator 430 typically comprises a biocompatible material, such as a polymer or metal. For some applications, force applicator 430 is coated with a drug and/or a radiopaque coating.

Force applicator 430 is adapted to be placed around between 90 and 270 degrees of mitral valve 58 of heart 50, in a vicinity of annulus 60 of mitral valve 58. The ends of force applicator 430 are typically, but not necessarily, positioned in a vicinity of commissural cusps 78 of mitral valve 58. Force applicator 430 is configured such that at least two regions thereof (typically end regions 462) apply force, symbolically indicated by arrows 464, to a wall 466 of a heart chamber in a vicinity of commissural cusps 78. The heart chamber is the left ventricle and/or the left atrium. Such outwardly-applied force draws commissural cusps 78 away from one another, stretching mitral valve 58 and thereby bringing posterior cusp 56 and anterior cusp 59 of mitral valve 58 closer to one another.

For some applications, force applicator 430 is adapted to be placed around between 120 and 240 degrees, such as between 150 and 210 degrees, e.g., about 180 degrees, of mitral valve 58. For some applications, force applicator 430 is adapted to be placed substantially only around all or a portion of posterior cusp 56, i.e., substantially not around any portion of anterior cusp 59. For example, for these applications, the length of force applicator 430 surrounding posterior cusp 56 may be at least about 5 or at least about 10 times the length of any portion of force applicator 430 that may be surrounding anterior cusp 59. For other applications, force applicator 430 is adapted to be placed around all or a portion of anterior cusp 59, and not necessarily around any portion of posterior cusp 56.

Reference is made to FIGS. 19A and 19B, which are schematic illustrations of mitral valve 58 before and after placement of force applicator 430, respectively, in accordance with an embodiment of the present invention. FIG. 19A shows mitral valve 58 during systole, prior to the placement of force applicator 430. Posterior cusp 56 and anterior cusp 59 are slightly separated from one another, causing mitral valve regurgitation. FIG. 19B shows force applicator 430 placed around posterior cusp 56, and applying outward force (indicated by arrows 464) on a wall 468 of a heart chamber. Such outwardly-applied force draws commissural cusps 78 away from one another, stretching mitral valve 58 and thereby forcing posterior cusp 56 and anterior cusp 59 of mitral valve 58 closer to one another, and thereby preventing regurgitation. (Broken lines 469 show the shape of annulus 60 prior to placement of force applicator 430, for the sake of comparison with FIG. 19A.)

Reference is made to FIG. 20, which is a schematic illustration of a portion of force applicator 430 placed around a portion of posterior cusp 56, in accordance with an embodiment of the present invention. For some applications, force applicator 430 is placed in the space defined by ventricular wall 70 of left ventricle 72, a ventricular surface of posterior cusp 56 in a vicinity of annulus 60, and third-order chordae tendineae 74 (also called tertiary or basal chordae). (Third-order chordae 74, of which only two of many are shown in the figure for clarity of illustration, originate directly from the trabeculae carneae of ventricular wall 70, and attach to posterior cusp 56 in a vicinity of annulus 60.) Alternatively or additionally, the space is defined by second-order chordae tendineae (not shown in the figure). Further alternatively, force applicator 430 is adapted to be placed in a left atrium of the heart, in contact with or in a vicinity of mitral valve 58 (configuration not shown).

Reference is made to FIGS. 21A and 21B, which are schematic illustrations of mitral valve 58 before and after expansion of force applicator 430, respectively, in accordance with an embodiment of the present invention. FIG. 21A shows mitral valve 58 during systole, immediately after placement of force applicator 430, but prior to the outward expansion of the force applicator. Force applicator 430 is configured and placed such that there is a gap 490 between the force applicator and dilated wall 468 of the heart chamber. Posterior cusp 56 and anterior cusp 59 are slightly separated from one another, causing mitral valve regurgitation. FIG. 21B shows force applicator 430 after outward expansion of ends 462 of the force applicator, as symbolically indicated by arrows 492. Such outwardly-applied force, in addition to drawing commissural cusps 78 away from one another, draws heart wall 468 closer to force applicator 430 in a vicinity of gap 490. Such tightening of wall 468 against force applicator 430 may occur immediately upon outward expansion of force applicator 430, or may occur over time, e.g., within about one month of expansion of force applicator 430, as the heart adapts to and heals because of the placement of the force applicator.

In an embodiment of the present invention, a surface of force applicator 430 opposite heart wall 468 is configured to enhance fibrosis between the force applicator and the heart wall. For example, the surface may be roughened, and/or coated with a fibrosis-enhancing substance. The fibrosis holds tissue of the heart wall against the force applicator, thereby helping prevent future dilation of the heart. Thus, force applicator 430 actively changes the shape of the heart around the mitral valve, and the fibrosis helps maintain this new shape.

Reference is mage to FIG. 22, which is a schematic illustration of a configuration of force applicator 430, in accordance with an embodiment of the present invention. In this configuration, force applicator 430 comprises or is shaped to define one or more protruding extensions 94 at one or both ends 462 of the force applicator. The extensions increase the outward pushing of the force applicator on the heart wall.

Reference is made to FIG. 23, which is a schematic illustration of another configuration of force applicator 430, in accordance with an embodiment of the present invention. In this configuration, force applicator 430 comprises or is shaped to define one or more coupling elements, which are adapted to hold the force applicator in place after placement. For some applications, the coupling elements comprise one or more protrusions 496, oriented on the force applicator such that the protrusions contact and grip the wall of the heart. Typically, protrusions 496 are positioned in a vicinity of ends 462 of force applicator 430, and/or along the length of the force applicator, such as in a vicinity of a middle of the force applicator. For some applications, protrusions 496 are positioned at the ends of protecting extensions 494, described hereinabove with reference to FIG. 22 (configuration not shown). For other applications, the coupling elements are adapted to be coupled to the mitral valve, and/or to one or more chordae tendineae, such as third-order chordae tendineae 74, or second-order chordae tendineae (not shown in the figures). For these applications, the coupling elements may comprise, for example, hooks, sutures, or staples (configuration not shown).

Reference is made to FIG. 24, which is a schematic illustration of a procedure for introducing force applicator 430 into heart 50 of a subject, in accordance with an embodiment of the present invention. Typically, force applicator 430 is introducing into ventricle 72 by a catheter 481, which is typically introduced into ventricle 72 via ascending aorta 82. A surgeon typically guides force applicator 430 to a desired location using images of heart 50 captured using techniques known in the art. Alternatively or additionally, the surgeon employs an echocardiogram to determine if placement of force applicator 430 achieves closure of the mitral valve. For some applications, force applicator 430 is adjustable during placement, for example, as described hereinbelow with reference to FIG. 26 and/or FIG. 27. For such applications, if the device does not sufficiently close the valve, the surgeon may adjust the device in situ until the valve is sufficiently closed.

For some applications, force applicator 430 comprises, e.g., at a distal end thereof, one or more wireless position sensors, such as those manufactured by Biosense, Inc. (New Brunswick, N.J.), or otherwise known in the art. Alternatively or additionally, force applicator 430 comprises, e.g., at a distal end thereof, one or more sensors for aiding navigation, such as an ultrasound sensor, an infrared sensor, or an optical sensor. For some applications, force applicator 430 comprises a steering mechanism, such as those known in the art of coronary catheter navigation. For some applications, the surgeon magnetically navigates force applicator 430, such as using techniques described in U.S. Pat. Nos. 6,817,364 or 6,522,909 to Garibaldi et al., or U.S. Pat. No. 6,475,223 to Werp et al., which are incorporated herein by reference, mutatis mutandis.

Reference is made to FIG. 25, which is a schematic illustration of a distal end 484 of catheter 481, in accordance with an embodiment of the present invention. In this embodiment, the distal end of catheter 481 opens laterally, rather than at its end, so as to guide force applicator 430 towards mitral valve 58 after the catheter is inserted into left ventricle 72.

Reference is made to FIG. 26, which is a schematic illustration of an adjustment mechanism 500 for force applicator 430, in accordance with an embodiment of the present invention. Adjustment mechanism 500 comprises a center wheel 502, which is configured to move ends 462 of force applicator 430 closer and farther from one another, in a manner similar to a center wheel of a draftsman's compass.

Reference is made to FIG. 27, which is a schematic illustration of another adjustment mechanism 520 for force applicator 430, in accordance with an embodiment of the present invention. Adjustment mechanism 520 comprises one or more screws 522 in a vicinity of one or both ends 462 of force applicator 430. Rotation of screws 522 in one direction increases the pushing of end 462 into the heart wall, while rotation of the screws in the opposite direction decreases such pushing. For some applications, force applicator 430 comprises both adjustment mechanism 520 and adjustment mechanism 500, described hereinabove with reference to FIG. 26.

It will be appreciated that wireless force applicator 430 has been generally described herein as comprising a single force applicator, the scope of the present invention is not limited to a single force applicator, and includes the use of multiple force applicators in series and/or parallel with one another.

It will be appreciated by persons skilled in the art that the present invention is not limited in what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

1. A method for treating mitral valve regurgitation, comprising:

inserting an implant including a band around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of chordae tendineae of one or more types of chordae tendineae selected from the group consisting of: second-order chordae tendineae and third-order chordae tendineae, and by the inserting, contacting the band with one or more tissues selected from the group consisting of: one or more of the plurality of chordae tendineae and the ventricular surface of the posterior cusp; and
supporting the posterior cusp by pressing the band against the posterior cusp, the plurality of chordae tendineae, and the ventricular wall, by inflating the band.

2. The method according to claim 1, wherein inflating the band comprises inflating the band so as to hold the band in place.

3. The method according to claim 1, wherein inflating the band comprises inflating the band with a liquid that at least partially solidifies after inflation.

4. The method according to claim 1, wherein inflating the band does not comprise coupling either a distal or a proximal end of the band to any portion of the heart, other than by the inflating.

5. The method according to claim 1, wherein the plurality of chordae tendineae includes the third-order chordae tendineae.

6. The method according to claim 1, wherein the plurality of chordae tendineae includes the second-order chordae tendineae.

7. The method according to claim 1, wherein inserting comprises inserting the implant including the band around no portion of an anterior cusp of the valve.

8. The method according to claim 1, wherein inserting comprises inserting the implant including the band such that a first portion of the band surrounds the at least the portion of the posterior cusp and a second portion of the band surrounds at least a portion of an anterior cusp of the valve, and wherein a length of the first portion of the band that surrounds the at least the portion of the posterior cusp is at least 5 times a total length of the second portion of the band that surrounds the at least the portion of the anterior cusp of the valve.

9. The method according to claim 1, wherein at least a portion of the band includes an elastic material, configured to shorten a length of the band, and wherein inserting the implant including the band comprises inserting the implant including the band including the elastic material.

10. The method according to claim 1, wherein the plurality of chordae tendineae comprises at least a first chorda tendinea and a second chorda tendinea, and wherein the method further comprises coupling a distal end and a proximal end of the band to the first chorda tendinea and the second chorda tendinea, respectively, each of the first and second chordae tendineae selected from the group consisting of: one of the third-order chordae tendineae, and a first-order chorda tendinea that inserts on a commissural cusp of the mitral valve.

11. The method according to claim 10, wherein coupling the distal end and the proximal end of the band to the first chorda tendinea and the second chorda, respectively, comprises tightening the annulus of the valve.

12. The method according to claim 10, wherein coupling the distal end and the proximal end of the band comprises:

coupling a distal coupling element at the distal end of the band to the first chorda tendinea; and
coupling a proximal coupling element at the proximal end of the band to the second chorda tendinea.

13. The method according to claim 12, wherein the distal and proximal coupling elements include respective hooks, and wherein coupling the distal and proximal coupling elements comprises hooking the distal and proximal coupling elements to the first and second chordae tendineae, respectively.

Referenced Cited
U.S. Patent Documents
3604488 September 1971 Wishart et al.
3656185 April 1972 Carpentier
3840018 October 1974 Heifetz
3898701 August 1975 La Russa
4042979 August 23, 1977 Angell
4118805 October 10, 1978 Reimels
4261342 April 14, 1981 Aranguren Duo
4290151 September 22, 1981 Massana
4434828 March 6, 1984 Trincia
4473928 October 2, 1984 Johnson
4602911 July 29, 1986 Ahmadi et al.
4625727 December 2, 1986 Leiboff
4712549 December 15, 1987 Peters et al.
4778468 October 18, 1988 Hunt et al.
4917698 April 17, 1990 Carpenter et al.
4961738 October 9, 1990 Mackin
5061277 October 29, 1991 Carpentier et al.
5104407 April 14, 1992 Lam et al.
5108420 April 28, 1992 Marks
5201880 April 13, 1993 Wright
5258008 November 2, 1993 Wilk
5300034 April 5, 1994 Behnke et al.
5306296 April 26, 1994 Wright et al.
5325845 July 5, 1994 Adair
5450860 September 19, 1995 O'Connor
5477856 December 26, 1995 Lundquist
5593424 January 14, 1997 Northrup, III
5601572 February 11, 1997 Middleman
5669919 September 23, 1997 Sanders et al.
5674279 October 7, 1997 Wright et al.
5683402 November 4, 1997 Cosgrove
5709695 January 20, 1998 Northrup
5716370 February 10, 1998 Williamson et al.
5716397 February 10, 1998 Myers
5728116 March 17, 1998 Rosenman
5730150 March 24, 1998 Peppel
5749371 May 12, 1998 Zadini
5810882 September 22, 1998 Bolduc
5824066 October 20, 1998 Gross
5843120 December 1, 1998 Israel et al.
5855614 January 5, 1999 Stevens et al.
5876373 March 2, 1999 Giba et al.
5935098 August 10, 1999 Blaisdell
5957953 September 28, 1999 DiPoto et al.
5961440 October 5, 1999 Schweich et al.
5961539 October 5, 1999 Northrup, III et al.
5984959 November 16, 1999 Robertson et al.
6042554 March 28, 2000 Rosenman
6045497 April 4, 2000 Schweich et al.
6050936 April 18, 2000 Schweich et al.
6059715 May 9, 2000 Schweich et al.
6074401 June 13, 2000 Gardiner et al.
6074417 June 13, 2000 Peredo
6102945 August 15, 2000 Campbell
6106550 August 22, 2000 Magovern
6110200 August 29, 2000 Hinnenkamp
6143024 November 7, 2000 Campbell
6159240 December 12, 2000 Sparer
6165119 December 26, 2000 Schweich et al.
6174332 January 16, 2001 Loch
6183411 February 6, 2001 Mortier
6187040 February 13, 2001 Wright
6217610 April 17, 2001 Carpentier
6231602 May 15, 2001 Carpentier
6251092 June 26, 2001 Qin et al.
6296656 October 2, 2001 Bolduc et al.
6315784 November 13, 2001 Djurovic
6319281 November 20, 2001 Patel
6332893 December 25, 2001 Mortier et al.
6402780 June 11, 2002 Williamson, IV
6406420 June 18, 2002 McCarthy et al.
6406493 June 18, 2002 Tu et al.
6451054 September 17, 2002 Stevens
6470892 October 29, 2002 Forsell
6503274 January 7, 2003 Howanec et al.
6524338 February 25, 2003 Gundry
6537314 March 25, 2003 Langberg et al.
6547801 April 15, 2003 Dargent
6554845 April 29, 2003 Fleenor
6564805 May 20, 2003 Garrison et al.
6565603 May 20, 2003 Cox
6569198 May 27, 2003 Wilson et al.
6579297 June 17, 2003 Bicke et al.
6589160 July 8, 2003 Schweich et al.
6602288 August 5, 2003 Cosgrove
6602289 August 5, 2003 Colvin et al.
6613078 September 2, 2003 Barone
6613079 September 2, 2003 Wolinsky et al.
6619291 September 16, 2003 Hlavka et al.
6626899 September 30, 2003 Houser et al.
6626930 September 30, 2003 Allen et al.
6629534 October 7, 2003 St. Goar et al.
6629921 October 7, 2003 Schweich et al.
6651671 November 25, 2003 Donlon et al.
6682558 January 27, 2004 Tu et al.
6689164 February 10, 2004 Seguin
6695866 February 24, 2004 Kuehn et al.
6702826 March 9, 2004 Liddicoat et al.
6702846 March 9, 2004 Mikus et al.
6706065 March 16, 2004 Langberg et al.
6709456 March 23, 2004 Langberg et al.
6711444 March 23, 2004 Koblish
6718985 April 13, 2004 Hlavka et al.
6719786 April 13, 2004 Ryan
6723038 April 20, 2004 Schroeder et al.
6726716 April 27, 2004 Marquez
6726717 April 27, 2004 Alfieri et al.
6730121 May 4, 2004 Ortiz et al.
6749630 June 15, 2004 McCarthy et al.
6752813 June 22, 2004 Foldfarb et al.
6764510 July 20, 2004 Vidlund et al.
6786924 September 7, 2004 Ryan et al.
6786925 September 7, 2004 Schoon et al.
6790231 September 14, 2004 Liddicoat et al.
6797001 September 28, 2004 Mathis et al.
6797002 September 28, 2004 Spence
6802319 October 12, 2004 Stevens et al.
6805710 October 19, 2004 Bolling et al.
6855126 February 15, 2005 Flinchbaugh
6858039 February 22, 2005 McCarthy
6884250 April 26, 2005 Monassevitch et al.
6893459 May 17, 2005 Macoviak
6908482 June 21, 2005 McCarthy et al.
6918917 July 19, 2005 Nguyen et al.
6926730 August 9, 2005 Nguyen et al.
6960217 November 1, 2005 Bolduc
6964684 November 15, 2005 Ortiz et al.
6976995 December 20, 2005 Mathis et al.
6986775 January 17, 2006 Morales et al.
6989028 January 24, 2006 Lashinski et al.
6997951 February 14, 2006 Solem et al.
7004176 February 28, 2006 Lau
7011669 March 14, 2006 Kimblad
7011682 March 14, 2006 Lashinski et al.
7037334 May 2, 2006 Hlavka et al.
7077862 July 18, 2006 Vidlund
7087064 August 8, 2006 Hyde
7101395 September 5, 2006 Tremulis
7112207 September 26, 2006 Allen et al.
7118595 October 10, 2006 Ryan
7125421 October 24, 2006 Tremulis et al.
7150737 December 19, 2006 Purdy et al.
7159593 January 9, 2007 McCarthy
7166127 January 23, 2007 Spence
7169187 January 30, 2007 Datta et al.
7172625 February 6, 2007 Shu et al.
7175660 February 13, 2007 Cartledge et al.
7186262 March 6, 2007 Saadat
7186264 March 6, 2007 Liddicoat
7189199 March 13, 2007 McCarthy et al.
7192443 March 20, 2007 Solem
7226467 June 5, 2007 Lucatero et al.
7226477 June 5, 2007 Cox
7229452 June 12, 2007 Kayan
7238191 July 3, 2007 Bachmann
7294148 November 13, 2007 McCarthy
7297150 November 20, 2007 Cartledge et al.
7311728 December 25, 2007 Solem et al.
7311729 December 25, 2007 Mathis
7314485 January 1, 2008 Mathis
7316710 January 8, 2008 Cheng et al.
7329280 February 12, 2008 Bolling et al.
7335213 February 26, 2008 Hyde et al.
7361190 April 22, 2008 Shoulian
7364588 April 29, 2008 Mathis
7377941 May 27, 2008 Rhee et al.
7390329 June 24, 2008 Westra et al.
7404824 July 29, 2008 Webler et al.
7431692 October 7, 2008 Zollinger et al.
7442207 October 28, 2008 Rafiee
7452376 November 18, 2008 Lim et al.
7455690 November 25, 2008 Cartledge et al.
7485142 February 3, 2009 Milo
7500989 March 10, 2009 Solem et al.
7507252 March 24, 2009 Lashinski et al.
7510577 March 31, 2009 Moaddeb
7527647 May 5, 2009 Spence
7530995 May 12, 2009 Quijano
7549983 June 23, 2009 Roue et al.
7562660 July 21, 2009 Saadat
7563267 July 21, 2009 Goldfarb et al.
7563273 July 21, 2009 Goldfarb et al.
7569062 August 4, 2009 Kuehn
7588582 September 15, 2009 Starksen et al.
7591826 September 22, 2009 Alferness
7604646 October 20, 2009 Goldfarb et al.
7608091 October 27, 2009 Goldfarb et al.
7608103 October 27, 2009 McCarthy
7618449 November 17, 2009 Tremulis et al.
7632303 December 15, 2009 Stalker et al.
7635329 December 22, 2009 Goldfarb et al.
7635386 December 22, 2009 Gammie
7655015 February 2, 2010 Goldfarb et al.
7666204 February 23, 2010 Thornton
7682319 March 23, 2010 Martin
7682369 March 23, 2010 Seguin
7686822 March 30, 2010 Shayani
7699892 April 20, 2010 Rafiee
7704269 April 27, 2010 Goar
7753924 July 13, 2010 Starksen et al.
7871433 January 18, 2011 Lattouf
7883538 February 8, 2011 To
7927371 April 19, 2011 Navia et al.
7988725 August 2, 2011 Gross et al.
7992567 August 9, 2011 Hirotsuka
7993368 August 9, 2011 Gambale et al.
7993397 August 9, 2011 Lashinski
8034103 October 11, 2011 Burriesci
8070804 December 6, 2011 Hyde
8070805 December 6, 2011 Vidlund
8075616 December 13, 2011 Solem
8100964 January 24, 2012 Spence
8123800 February 28, 2012 McCarthy
8123801 February 28, 2012 Milo
8142493 March 27, 2012 Spence et al.
8142495 March 27, 2012 Hasenkam
8142496 March 27, 2012 Berreklouw
8147542 April 3, 2012 Maisano et al.
8152844 April 10, 2012 Rao
8163013 April 24, 2012 Machold
8187324 May 29, 2012 Webler
8202315 June 19, 2012 Hlavka
8206439 June 26, 2012 Gomez-Duran
8226711 July 24, 2012 Mortier
8231671 July 31, 2012 Kim
8241351 August 14, 2012 Cabiri
8252050 August 28, 2012 Maisano et al.
8262725 September 11, 2012 Subramanian
8277502 October 2, 2012 Miller
8287584 October 16, 2012 Salahieh
8287591 October 16, 2012 Keidar
8323334 December 4, 2012 Deem et al.
8328868 December 11, 2012 Paul et al.
8333777 December 18, 2012 Schaller et al.
8349002 January 8, 2013 Milo
8353956 January 15, 2013 Miller et al.
8357195 January 22, 2013 Kuehn
8382829 February 26, 2013 Call
8393517 March 12, 2013 Milo
8430926 April 30, 2013 Kirson
8475491 July 2, 2013 Milo
8480732 July 9, 2013 Subramanian
8500800 August 6, 2013 Maisano
8518107 August 27, 2013 Tsukashima
8523881 September 3, 2013 Cabiri
8523940 September 3, 2013 Richardson
8545553 October 1, 2013 Zipory
8551161 October 8, 2013 Dolan
8591576 November 26, 2013 Hasenkam et al.
8608797 December 17, 2013 Gross
8628571 January 14, 2014 Hacohen
8715342 May 6, 2014 Zipory
8734467 May 27, 2014 Miller et al.
8778021 July 15, 2014 Cartledge
8795298 August 5, 2014 Hernlund
8808371 August 19, 2014 Cartledge
8845717 September 30, 2014 Khairkhahan et al.
8852272 October 7, 2014 Gross
8858623 October 14, 2014 Miller et al.
8888843 November 18, 2014 Khairkhahan et al.
8911494 December 16, 2014 Hammer
8926695 January 6, 2015 Gross et al.
8940042 January 27, 2015 Miller et al.
9011530 April 21, 2015 Reich et al.
9017399 April 28, 2015 Gross
9119719 September 1, 2015 Zipory
9125632 September 8, 2015 Loulmet
9173646 November 3, 2015 Fabro
9226825 January 5, 2016 Starksen
20010021874 September 13, 2001 Carpentier
20020029080 March 7, 2002 Mortier et al.
20020082525 June 27, 2002 Oslund
20020087048 July 4, 2002 Brock et al.
20020103532 August 1, 2002 Langberg et al.
20020151961 October 17, 2002 Lashinski et al.
20020151970 October 17, 2002 Garrison
20020173841 November 21, 2002 Ortiz et al.
20020177904 November 28, 2002 Huxel et al.
20030018358 January 23, 2003 Saadat
20030050693 March 13, 2003 Quijano et al.
20030078465 April 24, 2003 Pai et al.
20030078653 April 24, 2003 Vesely et al.
20030083742 May 1, 2003 Spence
20030105519 June 5, 2003 Fasol et al.
20030120340 June 26, 2003 Liska
20030130731 July 10, 2003 Vidlund et al.
20030167062 September 4, 2003 Gambale et al.
20030191528 October 9, 2003 Quijano et al.
20030199974 October 23, 2003 Lee et al.
20030204195 October 30, 2003 Keane
20030229350 December 11, 2003 Kay
20030229395 December 11, 2003 Cox
20030233142 December 18, 2003 Morales et al.
20040019377 January 29, 2004 Taylor
20040024451 February 5, 2004 Johnson et al.
20040039442 February 26, 2004 St. Goar et al.
20040049207 March 11, 2004 Goldfarb et al.
20040059413 March 25, 2004 Argento
20040092962 May 13, 2004 Thornton et al.
20040122448 June 24, 2004 Levine
20040122514 June 24, 2004 Fogarty et al.
20040127982 July 1, 2004 Machold et al.
20040127983 July 1, 2004 Mortier et al.
20040133220 July 8, 2004 Lashinski
20040133274 July 8, 2004 Webler
20040138744 July 15, 2004 Lashinski et al.
20040138745 July 15, 2004 Macoviak et al.
20040148019 July 29, 2004 Vidlund et al.
20040148020 July 29, 2004 Vidlund et al.
20040148021 July 29, 2004 Cartledge et al.
20040153146 August 5, 2004 Lashinski et al.
20040172046 September 2, 2004 Hlavka
20040181287 September 16, 2004 Gellman
20040186566 September 23, 2004 Hindrichs
20040193191 September 30, 2004 Starksen et al.
20040236419 November 25, 2004 Milo
20040243227 December 2, 2004 Starksen et al.
20040249453 December 9, 2004 Cartledge
20040260317 December 23, 2004 Bloom et al.
20040260393 December 23, 2004 Rahdert et al.
20040260394 December 23, 2004 Douk et al.
20040267358 December 30, 2004 Reitan
20050004668 January 6, 2005 Aklog
20050010287 January 13, 2005 Macoviak et al.
20050010787 January 13, 2005 Tarbouriech
20050016560 January 27, 2005 Voughlohn
20050055038 March 10, 2005 Kelleher et al.
20050055087 March 10, 2005 Starksen
20050060030 March 17, 2005 Lashinski et al.
20050065601 March 24, 2005 Lee et al.
20050070999 March 31, 2005 Spence
20050075727 April 7, 2005 Wheatley
20050085903 April 21, 2005 Lau
20050090827 April 28, 2005 Gedebou
20050096740 May 5, 2005 Langberg et al.
20050107812 May 19, 2005 Starksen
20050107871 May 19, 2005 Realyvasquez et al.
20050119734 June 2, 2005 Spence et al.
20050125002 June 9, 2005 Baran et al.
20050125011 June 9, 2005 Spence et al.
20050131533 June 16, 2005 Alfieri
20050137686 June 23, 2005 Salahieh
20050137695 June 23, 2005 Salahieh et al.
20050171601 August 4, 2005 Cosgrove et al.
20050177180 August 11, 2005 Kaganov et al.
20050177228 August 11, 2005 Solem et al.
20050187613 August 25, 2005 Bolduc et al.
20050192596 September 1, 2005 Jugenheimer et al.
20050197696 September 8, 2005 Gomez Duran
20050203549 September 15, 2005 Realyvasquez
20050203606 September 15, 2005 VanCamp
20050216039 September 29, 2005 Lederman
20050216079 September 29, 2005 MaCoviak
20050222665 October 6, 2005 Aranyi
20050222678 October 6, 2005 Lashinski et al.
20050288778 December 29, 2005 Shaoulian et al.
20050288781 December 29, 2005 Moaddeb et al.
20060004442 January 5, 2006 Spenser
20060004443 January 5, 2006 Liddicoat et al.
20060020326 January 26, 2006 Bolduc et al.
20060020327 January 26, 2006 Lashinski et al.
20060020333 January 26, 2006 Lashinski et al.
20060020336 January 26, 2006 Liddicoat
20060025787 February 2, 2006 Morales et al.
20060025858 February 2, 2006 Alameddine
20060030885 February 9, 2006 Hyde
20060041319 February 23, 2006 Taylor et al.
20060052868 March 9, 2006 Mortier
20060069429 March 30, 2006 Spence et al.
20060074486 April 6, 2006 Liddicoat
20060085012 April 20, 2006 Dolan
20060095009 May 4, 2006 Lampropoulos
20060116757 June 1, 2006 Lashinski et al.
20060129166 June 15, 2006 Lavelle
20060149280 July 6, 2006 Harvine et al.
20060149368 July 6, 2006 Spence
20060161265 July 20, 2006 Levine et al.
20060184240 August 17, 2006 Jimenez
20060184242 August 17, 2006 Lichtenstein
20060195134 August 31, 2006 Crittenden
20060241656 October 26, 2006 Starksen et al.
20060241748 October 26, 2006 Lee et al.
20060247763 November 2, 2006 Slater
20060259135 November 16, 2006 Navia
20060271175 November 30, 2006 Woolfson
20060282161 December 14, 2006 Huyn et al.
20060287661 December 21, 2006 Bolduc
20060287716 December 21, 2006 Banbury et al.
20070016287 January 18, 2007 Cartledge et al.
20070016288 January 18, 2007 Gurskis
20070027533 February 1, 2007 Douk
20070027536 February 1, 2007 Mihaljevic et al.
20070038221 February 15, 2007 Fine et al.
20070049942 March 1, 2007 Hindrichs et al.
20070049970 March 1, 2007 Belef et al.
20070051377 March 8, 2007 Douk et al.
20070055206 March 8, 2007 To et al.
20070061010 March 15, 2007 Hauser et al.
20070066863 March 22, 2007 Rafiee et al.
20070078297 April 5, 2007 Rafiee et al.
20070080188 April 12, 2007 Spence et al.
20070112359 May 17, 2007 Kimura
20070112422 May 17, 2007 Dehdashtian
20070112425 May 17, 2007 Schaller
20070118151 May 24, 2007 Davidson
20070118154 May 24, 2007 Crabtree
20070118213 May 24, 2007 Loulmet
20070118215 May 24, 2007 Moaddeb
20070142907 June 21, 2007 Moaddeb
20070162111 July 12, 2007 Fukamachi et al.
20070198082 August 23, 2007 Kapadia et al.
20070213582 September 13, 2007 Zollinger et al.
20070219558 September 20, 2007 Deutsch
20070233239 October 4, 2007 Navia et al.
20070239208 October 11, 2007 Crawford
20070244555 October 18, 2007 Rafiee et al.
20070244556 October 18, 2007 Rfiee et al.
20070250160 October 25, 2007 Rafiee
20070255397 November 1, 2007 Ryan et al.
20070255400 November 1, 2007 Parravicini et al.
20070270755 November 22, 2007 Von
20070282375 December 6, 2007 Hindrichs et al.
20070295172 December 27, 2007 Swartz
20080004697 January 3, 2008 Lichtenstein et al.
20080027483 January 31, 2008 Cartledge
20080035160 February 14, 2008 Woodson et al.
20080039935 February 14, 2008 Buch
20080051703 February 28, 2008 Thornton et al.
20080058595 March 6, 2008 Snoke et al.
20080065011 March 13, 2008 Marchand
20080065204 March 13, 2008 Mackoviak
20080086203 April 10, 2008 Roberts
20080091257 April 17, 2008 Andreas et al.
20080097523 April 24, 2008 Bolduc et al.
20080140116 June 12, 2008 Bonutti
20080167714 July 10, 2008 St. Goar
20080177382 July 24, 2008 Hyde
20080195126 August 14, 2008 Solem
20080195200 August 14, 2008 Vidlund
20080208265 August 28, 2008 Frazier et al.
20080221672 September 11, 2008 Lamphere
20080228265 September 18, 2008 Spence
20080243245 October 2, 2008 Thambar
20080262609 October 23, 2008 Gross et al.
20080275469 November 6, 2008 Fanton et al.
20080275551 November 6, 2008 Alfieri
20080281411 November 13, 2008 Berreklouw
20080288044 November 20, 2008 Osborne
20080288062 November 20, 2008 Andrieu et al.
20090043153 February 12, 2009 Zollinger et al.
20090043381 February 12, 2009 Macoviak
20090054969 February 26, 2009 Salahieh
20090076586 March 19, 2009 Hauser
20090076600 March 19, 2009 Quinn
20090088837 April 2, 2009 Gillinov
20090099650 April 16, 2009 Bolduc et al.
20090105816 April 23, 2009 Olsen et al.
20090125102 May 14, 2009 Cartledge
20090149872 June 11, 2009 Gross
20090171439 July 2, 2009 Nissl
20090177266 July 9, 2009 Powell et al.
20090177274 July 9, 2009 Scorsin
20090222083 September 3, 2009 Nguyen
20090248148 October 1, 2009 Shaolian
20090254103 October 8, 2009 Deutsch
20090259307 October 15, 2009 Gross et al.
20090264994 October 22, 2009 Saadat
20090264995 October 22, 2009 Subramanian
20090287231 November 19, 2009 Brooks et al.
20090287304 November 19, 2009 Dahlgren
20090299409 December 3, 2009 Coe
20090326648 December 31, 2009 Machold et al.
20100023117 January 28, 2010 Yoganathan
20100023118 January 28, 2010 Medlock et al.
20100030014 February 4, 2010 Ferrazzi
20100030328 February 4, 2010 Seguin
20100042147 February 18, 2010 Janovsky et al.
20100063586 March 11, 2010 Hasenkam
20100076499 March 25, 2010 McNamara et al.
20100094248 April 15, 2010 Nguyen et al.
20100121435 May 13, 2010 Subramanian
20100121437 May 13, 2010 Subramanian
20100130992 May 27, 2010 Machold et al.
20100152845 June 17, 2010 Bloom et al.
20100161041 June 24, 2010 Maisano et al.
20100161042 June 24, 2010 Maisano et al.
20100161043 June 24, 2010 Maisano et al.
20100161047 June 24, 2010 Cabiri
20100168845 July 1, 2010 Wright
20100174358 July 8, 2010 Rabkin et al.
20100179574 July 15, 2010 Longoria
20100211166 August 19, 2010 Miller et al.
20100234935 September 16, 2010 Bashiri et al.
20100249915 September 30, 2010 Zhang
20100249920 September 30, 2010 Bolling
20100262232 October 14, 2010 Annest
20100262233 October 14, 2010 He
20100280603 November 4, 2010 Maisano et al.
20100280604 November 4, 2010 Zipory et al.
20100280605 November 4, 2010 Hammer
20100286628 November 11, 2010 Gross
20100286767 November 11, 2010 Zipory
20100324598 December 23, 2010 Anderson
20110004298 January 6, 2011 Lee et al.
20110011917 January 20, 2011 Loulmet
20110029066 February 3, 2011 Gilad
20110035000 February 10, 2011 Nieminen et al.
20110066231 March 17, 2011 Cartledge
20110071626 March 24, 2011 Wright et al.
20110082538 April 7, 2011 Dahlgren et al.
20110087146 April 14, 2011 Ryan et al.
20110093002 April 21, 2011 Rucker et al.
20110106245 May 5, 2011 Miller et al.
20110106247 May 5, 2011 Miller
20110118832 May 19, 2011 Punjabi
20110166649 July 7, 2011 Gross et al.
20110184510 July 28, 2011 Maisano et al.
20110190879 August 4, 2011 Bobo et al.
20110202130 August 18, 2011 Cartledge et al.
20110208283 August 25, 2011 Rust
20110224785 September 15, 2011 Hacohen
20110230961 September 22, 2011 Langer
20110238088 September 29, 2011 Bolduc
20110257633 October 20, 2011 Cartledge
20110257728 October 20, 2011 Kuehn
20110264208 October 27, 2011 Duffy
20110276062 November 10, 2011 Bolduc
20110282361 November 17, 2011 Miller
20110288635 November 24, 2011 Miller
20110301698 December 8, 2011 Miller et al.
20120022557 January 26, 2012 Cabiri
20120022644 January 26, 2012 Reich
20120035712 February 9, 2012 Maisano
20120078355 March 29, 2012 Zipory
20120078359 March 29, 2012 Li
20120095552 April 19, 2012 Spence
20120123531 May 17, 2012 Tsukashima
20120136436 May 31, 2012 Cabiri
20120143323 June 7, 2012 Hasenkam
20120150290 June 14, 2012 Gabbay
20120245604 September 27, 2012 Tegzes
20120271198 October 25, 2012 Whittaker
20120283757 November 8, 2012 Miller
20120296349 November 22, 2012 Smith et al.
20120296417 November 22, 2012 Hill et al.
20120296419 November 22, 2012 Richardson et al.
20120310330 December 6, 2012 Buchbinder
20120323313 December 20, 2012 Seguin
20120330410 December 27, 2012 Hammer
20120330411 December 27, 2012 Gross
20130023758 January 24, 2013 Fabro
20130030522 January 31, 2013 Rowe et al.
20130035759 February 7, 2013 Gross
20130079873 March 28, 2013 Migliazza
20130090724 April 11, 2013 Subramanian
20130096672 April 18, 2013 Reich
20130096673 April 18, 2013 Hill
20130116780 May 9, 2013 Miller
20130123910 May 16, 2013 Cartledge
20130131792 May 23, 2013 Miller
20130172992 July 4, 2013 Gross
20130197632 August 1, 2013 Kovach
20130204361 August 8, 2013 Adams
20130226289 August 29, 2013 Shaolian
20130226290 August 29, 2013 Yellin
20130297013 November 7, 2013 Klima et al.
20130304093 November 14, 2013 Serina
20130325118 December 5, 2013 Cartledge
20140135799 May 15, 2014 Henderson
20140142619 May 22, 2014 Serina
20140148849 May 29, 2014 Serina
20140163690 June 12, 2014 White
20140188140 July 3, 2014 Meier
20140207231 July 24, 2014 Hacohen et al.
20140243894 August 28, 2014 Groothuis
20140303649 October 9, 2014 Nguyen
20140303720 October 9, 2014 Sugimoto
20140309730 October 16, 2014 Alon
20140343668 November 20, 2014 Zipory
20140379006 December 25, 2014 Sutherland
20150018940 January 15, 2015 Quill et al.
20150272734 October 1, 2015 Sheps
20150351906 December 10, 2015 Hammer
Foreign Patent Documents
0614342 September 1994 EP
1006905 June 2000 EP
0954257 August 2000 EP
1258437 November 2002 EP
087417 October 2003 EP
1266641 October 2004 EP
1034753 February 2005 EP
1562522 December 2008 EP
1258232 January 2009 EP
1420723 January 2009 EP
1903991 September 2009 EP
1418865 October 2009 EP
1531762 April 2010 EP
2274928 January 2011 EP
1450733 February 2011 EP
2445417 May 2012 EP
1861045 March 2015 EP
2349086 April 2015 EP
1465555 May 2015 EP
92/05093 April 1992 WO
96/39963 December 1996 WO
96/40344 December 1996 WO
97/01369 January 1997 WO
98/46149 October 1998 WO
99/30647 June 1999 WO
00/22981 April 2000 WO
01/26586 April 2001 WO
01/56457 August 2001 WO
02/085251 October 2002 WO
02/085252 October 2002 WO
03/047467 June 2003 WO
03/049647 June 2003 WO
WO03105667 December 2003 WO
2004/103434 December 2004 WO
2005/021063 March 2005 WO
2005/046488 May 2005 WO
2006/012013 February 2006 WO
2006/012038 February 2006 WO
2006/086434 August 2006 WO
2006/097931 September 2006 WO
2006/105084 October 2006 WO
2006/116558 November 2006 WO
2007/011799 January 2007 WO
2007/011799 January 2007 WO
2007/136783 November 2007 WO
2008/068756 June 2008 WO
2009130631 October 2009 WO
2010/004546 January 2010 WO
WO2010044851 April 2010 WO
2010/073246 July 2010 WO
2010/128502 November 2010 WO
2010/128503 November 2010 WO
2010150178 December 2010 WO
2011/051942 May 2011 WO
2011/067770 June 2011 WO
2011/089601 July 2011 WO
2011/148374 December 2011 WO
2012/014201 February 2012 WO
2012/176195 December 2012 WO
2013/078497 June 2013 WO
2013/088327 June 2013 WO
2014/195786 December 2014 WO
Other references
  • An Office Action dated Jun. 4, 2014, which issued during the prosecution of U.S. Appl. No. 12/840,463. 17 pages.
  • Notice of Allowance dated Jun. 25, 2014, which issued during the prosecution of U.S. Appl. No. 13/666,262. 8 pages.
  • O'Reilly S et al., “Heart valve surgery pushes the envelope,” Medtech Insight 8(3): 73, 99-108 (2006).
  • Dieter RS, “Percutaneous valve repair: Update on mitral regurgitation and endovascular approaches to the mitral valve,” Applications in Imaging, Cardiac Interventions, Supported by an educational grant from Amersham Health pp. 11-14 (2003).
  • Swain CP et al., “An endoscopically deliverable tissue-transfixing device for securing biosensors in the gastrointestinal tract,” Gastrointestinal Endoscopy 40(6): 730-734 (1994).
  • Odell JA et al., “Early Results of a Simplified Method of Mitral Valve Annuloplasty,” Circulation 92:150-154 (1995).
  • An International Search Report dated Sep. 8, 2009, which issued during the prosecution of Applicant's PCT/IL09/00593.
  • U.S. Appl. No. 60/873,075, filed Dec. 5, 2006.
  • An International Preliminary Report on Patentability dated Nov. 9, 2011, which issued during the prosecution of Applicant's PCT/IL2010/000357.
  • U.S. Appl. No. 60/902,146, filed Feb. 16, 2007.
  • An International Preliminary Report on Patentability dated Jun. 5, 2012, which issued during the prosecution of Applicant's PCT/IL2010/001024.
  • U.S. Appl. No. 61/001,013, filed Oct. 29, 2007.
  • An International Preliminary Report on Patentability dated Nov. 27, 2012, which issued during the prosecution of Applicant's PCT/IL2011/000404.
  • U.S. Appl. No. 61/132,295, filed Jun. 16, 2008.
  • A Restriction Requirement dated Apr. 19, 2010, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • “Two dimensional real-time ultrasonic imaging of the heart and great vessels”, Mayo Clin Proc. vol. 53:271-303, 1978.
  • An Office Action dated Mar. 29, 2011, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • An Office Action dated Aug. 2, 2011, which issued during the prosecution of U.S. Appl. No. 12/435,291.
  • A Restriction Requirement dated Mar. 30, 2012, which issued during the prosecution of U.S. Appl. No. 12/785,717.
  • An International Search Report and a Written Opinion both dated Jun. 10, 2010, which issued during the prosecution of Applicant's PCT/IL09/01209.
  • An Office Action dated Jan. 27, 2012, which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • An Office Action dated Apr. 6, 2010, which issued during the prosecution of Applicant's U.S. Appl. No. 12/484,512.
  • An Office Action dated Nov. 5, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • An International Search Report and a Written Opinion both dated Aug. 17, 2010, which issued during the prosecution of Applicant's PCT/IL10/00357.
  • Agarwal et al. International Cardiology Perspective Functional Tricuspid Regurgitation, Circ Cardiovasc Interv 2009;2;2;565-573 (2009).
  • Alfieri et al., “An effective technique to correct anterior mitral leaflet prolapse,” J Card Surg 14(6):468-470 (1999).
  • Alfieri et al., “The double orifice technique in mitral valve repair: a simple solution for complex problems,” Journal of Thoracic Cardiovascular Surgery 122:674-681 (2001).
  • Alfieri et al., “The edge to edge technique,” The European Association for Cardio-Thoracic Surgery 14th Annual Meeting Oct. 7-11, Book of Procees. (2000).
  • An International Preliminary Report on Patentability dated Jun. 29, 2011, which issued during the prosecution of Applicant's PCT/IL2009/001209.
  • U.S. Appl. No. 61/283,445, filed Dec. 2, 2009.
  • Alfieri, “The edge-to-edge repair of the mitral valve,” [Abstract] 6th Annual NewEra Cardiac Care: Innovation & Technology, Heart Surg Forum pp. 103, 2000.
  • Dang NC et al. “Simplified Placement of Multiple Artificial Mitral Valve Chords,” The Heart Surgery Forum #2005-1005, 8 (3) (2005).
  • U.S. Appl. No. 61/265,936, filed Dec. 2, 2009.
  • An International Search Report and a Written Opinion both dated Feb. 10, 2011, which issued during the prosecution of Applicant's PCT/IL10/00890.
  • Alfieri et al.“Novel Suture Device for Beating-Heart Mitral Leaflet Approximation”, Ann Thorac Surg. 2002, 74:1488-1493.
  • A Notice of Allowance dated Jun. 26, 2012, which issued during the prosecution of U.S. Appl. No. 12/608,316.
  • An Office Action dated Jan. 23, 2012, which issued during the prosecution of U.S. Appl. No. 12/692,061.
  • An International Search Report and a Written Opinion, both dated May 19, 2011, which issued during the prosecution of Applicant's PCT/IL2011/00064.
  • A Supplementary European Search Report dated Feb. 1, 2011, which issued during the prosecution of Applicant's EP Patent Application No. 07849540.
  • An International Search Report together with Written Opinion both dated Mar. 30, 2011, which issued during the prosecution of Applicant's PCT/IL2010/001024.
  • An International Search Report and a Written Opinion both dated Feb. 22, 2013, which issued during the prosecution of Applicant's PCT/IL2012/50451.
  • An Office Action dated Aug. 6, 2012, which issued during the prosecution of U.S. Appl. No. 12/548,991.
  • An Office Action dated Jul. 20, 2012, which issued during the prosecution of U.S. Appl. No. 12/843,412.
  • An Office Action dated Aug. 24, 2012, which issued during the prosecution of U.S. Appl. No. 12/563,930.
  • An Office Action dated May 10, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,026.
  • An Office Action dated Mar. 9, 2012, which issued during the prosecution of U.S. Appl. No. 13/689,635.
  • A Restriction Requirement dated Sep. 14, 2012, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • An Office Action dated Sep. 28, 2011, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • An International Search Report and Written Opinion, both dated Nov. 8, 2010, which issued during the prosecution of Applicant's PCT/IL2010/000358.
  • An Office Action dated Dec. 29, 2011, which issued during the prosecution of U.S. Appl. No. 12/563,952.
  • An International Search Report and a Written Opinion both dated Nov. 23, 2011, which issued during the prosecution of Applicant's PCT/IL2011/000446.
  • An International Search Report and a Written Opinion both dated Nov. 11, 2011, which issued during the prosecution of Applicant's PCT/IL2011/000404.
  • An International Search Report dated Feb. 2, 2012, which issued during the prosecution of Applicant's PCT/IL2011/000600.
  • An International Preliminary Report on Patentability dated Nov. 9, 2011 which issued during the prosecution of Applicant's PCT/IL2010/000358.
  • An Office Action dated Jul. 6, 2012, which issued during the prosecution of U.S. Appl. No. 12/360,061.
  • An Office Action dated Aug. 4, 2010, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • An Office Action dated Nov. 14, 2011, which issued during the prosecution of U.S. Appl. No. 12/608,316.
  • An Office Action dated Jan. 17, 2013, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • An Office Action dated Feb. 12, 2013, which issued during the prosecution of U.S. Appl. No. 12/926,673.
  • Langer et al. Ring plus String: Papillary muscle repositioning as an adjunctive repair technique for ischemic mitral regurgitation, The Journal of Thoracic Cardiovascular surgery vol. 133 No. 1, Jan. 2007.
  • Langer et al. Ring+String, Successful Repair technique for ischemic mitral regurgitation with severe leaflet Tethering, The Department of Thoracic Cardiovascular surgery, Hamburg, Germany, Nov. 2008.
  • Notice of Allowance dated Apr. 27, 2012, which issued during the prosecution of U.S. Appl. No. 12/341,960.
  • Notice of Allowance dated Dec. 7, 2011, which issued during the prosecution of U.S. Appl. No. 12/435,291.
  • A Restriction Requirement dated Oct. 27, 2011, which issued during the prosecution of U.S. Appl. No. 12/563,952.
  • A Notice of Allowance dated May 24, 2012, which issued during the prosecution of U.S. Appl. No. 12/563,952.
  • A Notice of Allowance dated Apr. 3, 2013, which issued during the prosecution of U.S. Appl. No. 12/563,930.
  • U.S. Appl. No. 61/555,570, filed Nov. 4, 2011.
  • An Office Action dated Jan. 17, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • A Supplementary European Search Report dated Dec. 4, 2012, which issued during the prosecution of EP Patent Application No. 09834225.6.
  • An Office Action dated Feb. 4, 2013, which issued during the prosecution of U.S. Appl. No. 13/141,606.
  • An Office Action dated Jun. 7, 2013, which issued during the prosecution of U.S. Appl. No. 13/141,606.
  • An International Search Report and a Written Opinion both dated Dec. 6, 2012, which issued during the prosecution of Applicant's PCT/IL2012/000250.
  • An Office Action dated Apr. 2, 2013, which issued during the prosecution of U.S. Appl. No. 12/785,717.
  • An Office Action dated Apr. 1, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,476.
  • An Office Action dated Aug. 13, 2012, which issued during the prosecution of U.S. Appl. No. 13/044,694.
  • An Office Action dated Dec. 31, 2012, which issued during the prosecution of U.S. Appl. No. 13/044,694.
  • An Office Action dated Jul. 18, 2013, which issued during the prosecution of U.S. Appl. No. 13/044,694.
  • An Office Action dated Feb. 14, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,492.
  • An International Search Report and a Written Opinion both dated May 30, 2007, which issued during the prosecution of Applicant's PCT/IL2006/000342.
  • An International Preliminary Report on Patentability dated Sep. 18, 2007, which issued during the prosecution of Applicant's PCT/IL2006/000342.
  • Notice of Allowance dated Aug. 19, 2013 which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • Office Action dated Dec. 21, 2013 which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • Office Action dated Jun. 8, 2012 which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • Restriction Requirement dated Aug. 5, 2011 which issued during the prosecution of U.S. Appl. No. 11/908,906.
  • Office Action dated Dec. 16, 2013 which issued during the prosecution of U.S. Appl. No. 13/666,262.
  • An Office Action dated Oct. 2, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,492.
  • An Office Action dated Nov. 21, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,476.
  • An Office Action dated Dec. 18, 2013, which issued during the prosecution of U.S. Appl. No. 13/666,141.
  • An Office Action dated Dec. 19, 2013, which issued during the prosecution of U.S. Appl. No. 14/027,934.
  • Notice of Allowance dated Nov. 19, 2013, which issued during the prosecution of U.S. Appl. No. 12/795,192.
  • An International Preliminary Report on Patentability dated Dec. 23, 2013, which issued during the prosecution of Applicant's PCT/IL2012/000250.
  • U.S. Appl. No. 60/662,616, filed Mar. 17, 2005.
  • U.S. Appl. No. 60/700,542, filed Jul. 18, 2005.
  • An Office Action dated Oct. 6, 2010, which issued during the prosecution of U.S. Appl. No. 12/484,512.
  • An Office Action dated Jun. 13, 2012, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • Notice of Allowance dated Dec. 20, 2013, which issued during the prosecution of U.S. Appl. No. 12/437,103.
  • Notice of Allowance dated May 22, 2013 which issued during the prosecution of U.S. Appl. No. 12/689,635.
  • An Adversary Action dated Feb. 4, 2014, which issued during the prosecution of U.S. Appl. No. 13/167,476.
  • Office Action dated Feb. 3, 2014 which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • An Office Action dated Aug. 23, 2013, which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • Supplementary European Search Report dated Mar. 28, 2013, which issued during the prosecution of EP Patent Application No. 10772091.
  • An Office Action dated Nov. 30, 2012, which issued during the prosecution of U.S. Appl. No. 12/689,635.
  • U.S. Appl. No. 61/207,908, filed Feb. 17, 2009.
  • An Office Action dated Aug. 5, 2010 which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • An Office Action dated Feb. 17, 2010 which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • An Office Action dated Sep. 16, 2009 which issued during the prosecution of U.S. Appl. No. 11/950,930.
  • A communication from the European Patent Office dated Sep. 28, 2011 which issued during the prosecution of European Application No. 09834225.6.
  • A Notice of Allowance dated Sep. 18, 2012 which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • An Office Action dated May 30, 2012 which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • An Office Action dated Sep. 1, 2011 which issued during the prosecution of U.S. Appl. No. 12/706,868.
  • Requirement for Restriction dated Sep. 17, 2012 which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • Brennan, Jennifer, “510(k) Summary of Safety and Effectiveness,” Jan. 2008.
  • A Restriction Requirement dated Oct. 25, 2012, which issued during the prosecution of U.S. Appl. No. 13/167,444.
  • An Office Action dated Dec. 27, 2013, which issued during the prosecution of U.S. Appl. No. 12/785,717.
  • A Restriction Requirement dated Nov. 2, 2012, which issued during the prosecution of U.S. Appl. No. 13/167,492.
  • An Office Action dated May 6, 2013, which issued during the prosecution of U.S. Appl. No. 12/689,693.
  • Amplatzer® Septal Occluder. A patient guide to the Non-Surgical Closuer of the Atrial Septal Defect Using the Amplatzer Septal Occluder System, AGA Medical Corporation, Apr. 2008.
  • Amplatzer® Cribriform Occluder. A patient guide to Percutaneous, Transcatheter, Atrial Septal Defect Closuer, AGA Medical Corporation, Apr. 2008.
  • F. Maisano, The double-orifice technique as a standardized approach to treat mitral . . . , European Journal of Cardio-thoracic Surgery 17 (2000) 201-205.
  • Supplementary European Search Report dated Jan. 17, 2014, which issued during the prosecution of EP Patent Application No. 10772090.
  • Supplementary European Search Report dated Jan. 21, 2014, which issued during the prosecution of EP Patent Application No. 11 78 6226.
  • Amplatzer Cardiac Plug brochure (English pages), AGA Medical Corporation (Plymouth, MN) (copyright 2008-2010, downloaded Jan. 11, 2011).
  • Communication from EPC for EP 09834225.6 dated Mar. 23, 2015.
  • Office Action for U.S. Appl. No. 14/128,756 dated May 28, 2015.
  • International Search Report and Written Opinion for PCTIL2014050914 dated May 12, 2015.
  • Office Action for U.S. Appl. No. 12/996,954 dated Mar. 24, 2015.
  • Office Action for U.S. Appl. No. 14/027,934 dated Apr. 2, 2015.
  • Supplementary European Search Report for EP 11792047.0 dated Mar. 23, 2015.
  • An Office Action dated May 23, 2016, which issued during the prosecution of U.S. Appl. No. 14/209,171. 14 pages.
  • An Office Action dated Apr. 8, 2016, which issued during the prosecution of U.S. Appl. No. 14/141,228. 8 pages.
  • An Office Action dated Jun. 14, 2016, which issued during the prosecution of U.S. Appl. No. 14/273,155. 9 pages.
  • An Office Action dated Jun. 17, 2016, which issued during the prosecution of U.S. Appl. No. 14/357,040. 8 pages.
  • An Office Action dated Oct. 5, 2015, which issued during the prosecution of U.S. Appl. No. 14/246,417.
  • An Office Action dated Oct. 1, 2015, which issued during the prosecution of U.S. Appl. No. 14/141,228.
  • European Search Report dated Sep. 25, 2015 which issued during the prosecution of Applicant's European App No. 09794095.1.
  • An Office Action dated Nov. 17, 2015, which issued during the prosecution of U.S. Appl. No. 14/486,226.
  • European Search Report dated Nov. 4, 2015 which issued during the prosecution of Applicant's European App No. 10772091.4.
  • European Search Report dated Nov. 16, 2015 which issued during the prosecution of Applicant's European App No. 10826224.7.
  • An English Translation of an Office Action dated Nov. 24, 2015, which issued during the prosecution of Israel Patent Application No. 223448. (the relevant part only).
  • An International Search Report and a Written Opinion both dated Oct. 27, 2015, which issued during the prosecution of Applicant's PCT/IL2015/050792.
Patent History
Patent number: 9526613
Type: Grant
Filed: Nov 19, 2013
Date of Patent: Dec 27, 2016
Patent Publication Number: 20140148898
Assignee: Valtech Cardio Ltd. (Or Yehuda)
Inventors: Amir Gross (Tel Aviv), Yossi Gross (Moshav Mazor)
Primary Examiner: Christian Sevilla
Assistant Examiner: Seema Mathew
Application Number: 14/084,426
Classifications
Current U.S. Class: Adjustable (623/2.37)
International Classification: A61F 2/24 (20060101); A61B 17/00 (20060101);